Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Nocturia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Acupuncture group will receive 10 treatments of acupuncture over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.

The waitlist control group will not receive any acupuncture treatments during the 14-week waiting period. Patients in waitlist control group will have the option to receive up to 10 acupuncture treatments after a 14-week waiting period.

10 treatments of acupuncture over the course of 10 weeks

Acupuncture

Waitlist Control

Patients will complete Patient Reported Outcomes (PRO)

Questionnaires

Kevin Liou, MD

Jun Mao, MD, MSCE

Kevin Loiu, MD

Jun Mao, MSCE

The purpose of this study is to test whether acupuncture can improve nocturia in prostate cancer survivors. This is the first time acupuncture is being studied for nocturia in prostate cancer survivors. Researchers will see if acupuncture is a practical treatment option for prostate cancer survivors with nocturia. The study will also look at the effect acupuncture has on nocturia and other symptoms prostate cancer survivors experience such as insomnia, hot flashes, anxiety, depression, tiredness (fatigue), sexual dysfunction, and cognitive (mental) difficulties.

An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

Nocturia in Prostate Cancer Survivors - Acupuncture Pilot Study (NOCTURNAL)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

If a participant completes at least 8 out of 10 acupuncture sessions. Feasibility will be evaluated based on the respective definitions of success for the acupuncture.

Memorial Sloan Kettering Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

memory training 10 1-hour sessions with interventionist to be delivered over 6-8 weeks

Speed of processing training 10 1-hour sessions delivered over 6-8 weeks

Breast cancer survivors will be randomized to 1 of 3 groups: memory training, speed of process training or waitlist control

memory training

10 1-hour sessions delivered over 6-8 weeks

speed of processing training

Breast cancer survivors will receive the speed of processing training compact disc in the mail after study completion.

waitlist control

Diane Von Ah, PhD, RN, CNA

Andrew Saykin, PsyD

Frederick Unverzagt, PhD

Janet Carpenter, PhD, RN

Patrick Monahan, PhD

This is a randomized controlled trial to evaluate the ACTIVE memory training intervention and ACTIVE speed of processing training to waitlist, no-contact control conditions. Specific aims and hypotheses are:

Aim 1: Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors (BCS).

Hypothesis 1: BCS assigned to the memory intervention arm will perceive the intervention as more acceptable and useful than BCS assigned to the attention control condition.

Aim 2: Establish preliminary efficacy of the ACTIVE memory training intervention relative to the attention control and no-contact control conditions.

Hypothesis 2: Memory training will result in greater memory enhancement immediately post and 2-months post-intervention relative to attention control or no-contact control conditions.

Memory deficits are a prevalent, bothersome, and potentially debilitating symptom for millions of breast cancer survivors (BCS). Evidence-based treatment is difficult because there has been little intervention research in this area. Memory training may be a viable treatment option for BCS in need. Therefore, the purpose of this study is to examine the acceptability, usefulness, and preliminary efficacy of the memory training intervention from the Advanced Cognitive Training in Vital Elderly (ACTIVE) trial, the largest controlled trial of cognitive interventions in the behavioral sciences. The memory training intervention will be compared to attention control and no-contact control groups. Specific aims are to (1) evaluate the acceptability and usefulness of the memory intervention in BCS and (2) establish preliminary efficacy of the ACTIVE memory training intervention relative to attention control and no-contact control conditions. Acceptability and usefulness will be assessed through self-report. Memory will be assessed through objective neuropsychological tests. A total of 108 eligible BCS will be randomized to memory training, attention control, or no-contact control. A blinded and trained tester will perform data collection and neuropsychological testing at three time points: baseline prior to the intervention, immediately post-intervention, and 2 months post-intervention. Findings will provide information about the acceptability, usefulness, and preliminary efficacy of the ACTIVE memory training intervention on memory performance in BCS. Positive results will lead to a larger, full-scale study to determine efficacy of memory training interventions for BCS. Nursing interventional research in this area is vital to the development of evidence-based interventions to address memory deficits in BCS.

Memory Training Intervention for Breast Cancer Survivors

Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.

Preliminary efficacy established by objective neuropsychological tests and quality of life.

Post intervention efficacy established by objective neuropsychological tests and quality of life.

Indiana University

Associate Professor, Department Chair, School of Nursing

* The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions
* Mini relaxation practice
* Weekly goal check-ins
* RR-practice

The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being. Waitlist control receives the adapted 3RP program (3RP-AYA) approximately 2 months after study enrollment.

Waitlist control

The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.

3RP-AYA

Giselle K. Perez, PhD

This research study aims to explore the feasibility and acceptability of an adapted resiliency group program, called the Relaxation Response Resiliency Program (3RP-AYA), to reduce stress and promote stress-management among adolescents and young adults who have completed treatment for cancer.

The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH Benson-Henry Institute for Mind Body Medicine. The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.

The 3RP has not yet been carried out with adolescent or young adult individuals who have recently completed treatment for cancer. As such, the investigators have adapted the original 3RP to target the specific needs of adolescent and young adult patients who are transitioning off active treatment. The investigators are conducting this study to see if the adapted program, the 3RP-AYA, is effective at reducing stress and stress-related symptoms for people of at least age 16 who have completed treatment for cancer within the past five years.

A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors

A Stress Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors

Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility.

Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Qualitative information from experts and participants will be used to inform feasibility.

Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and satisfaction. Qualitative information from experts and patients will also inform acceptability.

National Cancer Institute (NCI)

Massachusetts General Hospital

Principal Investigator

* The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions
* Mini relaxation practice
* Weekly goal check-ins
* RR-practice

Waitlist control: The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being. Waitlist control receives the adapted 3RP program (3RP-AYA) approximately 2 months after study enrollment.

* The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions
* Mini relaxation practice
* Weekly goal check-ins
* RR-practice

  3RP-AYA: The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.

3RP Group Sessions

All participants who consented and completed the baseline survey

Enrolled Patients

Age, Continuous

Gender

Sex/Gender, Customized

Race/ethnicity

Race/Ethnicity, Customized

Months since treatment completion

This is a conservative number that consists of all patients who were officially enrolled in the trial (regardless of whether or not they began the intervention), defined as having consented and completed the baseline survey.

Dr. Giselle K. Perez

This consists of eligible individuals who were approached and informed about the study (thus had the opportunity to participate)

Total Individuals Approached

This consists of the total number of individuals who were eligible, were approached and informed about the study, and were offered the opportunity to participate.

3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll

Among treatment started, this consists of all participants who completed the 3RP-AYA.

Treatment Completers

Total number of patients who initiated the program.

3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program

How enjoyable was the program

How helpful was the program?

How relevant was the program?

How convenient was the program

How satisfied are you with the content?

Denominator is the number of individuals who responded to the acceptability measure.

Completed Post-treatment Survey Acceptability Items

These were inclusive of all responses to the acceptability items.

3RP-AYA Acceptability: Five Questions

The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions immediately after enrollment.

The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions 2-months after enrollment.

Overall Study

Nutritional and Metabolic Diseases

Calcinosis

Vascular Calcification

Metabolic Diseases

Calcium Metabolism Disorders

944 participants will receive a post-mammography results letter which includes information on their BAC results.

944 participants will receive a post-mammography results letter without BAC information, which is the current standard of care. These patients will receive BAC information following study completion (approximately 6 months after mammography).

The BAC-Enhanced Letter intervention includes enhancing the standard mammography results letter with a few additional lines of text informing patients of their personal BAC status.

BAC-Enhanced Letter

Patients randomized to this group will receive a standard post-mammography results letter which does not include any information about their personal BAC status. However, participants randomized to this group will be informed of their personal BAC findings at the end of their study participation (approximately 6 months after mammography).

Crystalinda Rapozo

Julie B. Schnur, Ph.D.

Guy H. Montgomery

Guy H. Montgomery, Ph.D.

The purpose of this research study is to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results to the standard results letter women receive after mammography. In addition to looking for potential breast cancer, research shows that mammograms can also detect the presence of calcifications within the breast arteries. Those calcifications can be associated with coronary artery disease. Right now, women are not routinely told whether or not they have BAC; that is, it's not part of standard practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about their BAC status more often. In this study, the team has two goals. First, the team wants to measure the rates of BAC in a large, diverse group of 14,875 women. Because most of the past research on BAC has largely been focused on White mammography patients, the researchers feel it is important to see if the results are similar or different in a more racially and ethnically diverse sample.

Second, the study team wants to understand the effects of giving women information on their BAC results as part of their standard post-mammography letter. Specifically, the study team wants to see how sharing that information might affect women's healthcare choices and lifestyle. The research will include 1,888 women in this second part of the study, which will be the first in the literature to explore women's reactions to BAC information. If research shows that women find the information useful, BAC information may be given to women regularly in the future.

Mammography and Breast Arterial Calcification: An Information-Sharing Trial

Enhancing the Public Health Benefits of Mammography Screening by Informing Women of Both Breast Cancer and Breast Arterial Calcification Results: A Randomized Trial to Promote Cardiovascular Health

There currently isn't a plan to share individual participant data (IPD) with other researchers as this is a single-center trial and all study investigators and personnel are affiliated with Mount Sinai.

Patients will be asked a YES/NO question asking them to report whether they have seen a healthcare provider to talk about their heart or coronary artery disease in the last six months. Patient's self-report responses will be confirmed via medical record review.

The Healthy Heart Score is a survey to assess patients' heart healthy behaviors. It assesses age, smoking, body mass index, exercise, alcohol, and a composite diet score. A higher score indicates a greater risk of cardiovascular disease.

Score has gender-specific algorithm that estimates 20-year CVD risk (https://healthyheartscore.sph.harvard.edu/) (DOI: 10.1161/JAHA.114.000954):

20-yr CVD risk (%) "Healthy Heart Score" = \[1 - 0. 9660 (exp \[W- 6.57301)\] × 100% where W= 0.10820 x age + 0.15285 (if past smoker) + 0.90138 (if current smoker) + 0.04676 × BMI - 0.01923 × g/d of alcohol + 0.0004 × (g/d of alcohol)2- 0.029251 × hrs/wk of physical activity - 0.05113 × diet score\* 20-yr CVD risk (%) "Healthy Heart Score" = \[1 - 0. 96368 (exp \[W-7.2437)\] × 100% where W= 0.13580 x age- 0.0005 x (age)2 + 0.06979 (if past smoker) + 0.42305 (if current smoker) +0.07424 × BMI - 0.00898 × g/d of alcohol + 0.0001 × (g/d of alcohol)2- 0.01755 × hrs/wk of physical activity - 0.06691 × diet score

Participants will respond to a single, self-report item (adapted from the 2019 NHIS survey item) which will ask if they have been told by a doctor or other health professional that they had coronary artery disease in the last 6 months. The item will be rated as, "yes, no, or don't know." Self-reported diagnosis will be confirmed via medical record review.

Illness representations will be assessed using the IPQ-R which have been adapted to include an addendum of Cardiovascular-Disease Related Worry Scale questions. Participants will be asked to rate items related to personal beliefs about CAD with regard to causal beliefs and on 8 subscales: identity (scale 0-13); timeline (scale 6-30); consequences (scale 6-30); personal control (scale 6-30); treatment control (scale 5-25); illness coherence (scale5-25); timeline cyclical (scale 4-20); and emotional representations (scale 6-30); and CVD related worry scale (scale3-13). Full scale from 41-216, higher scores represent a higher number of symptoms related to CAD, more positive beliefs about the controllability of disease, and a greater personal understanding of the condition.

Icahn School of Medicine at Mount Sinai

Professor, Department of Population Health Science and Policy

Behaviors and Mental Disorders

Anxiety Disorders

Depression

Depressive Disorder

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

The intervention group will immediately receive 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy.

The control group will be on a waiting list to participate in Internet-delivered MBCT after the 6-months follow-up time has passed.

Internet-delivered Mindfulness-Based Cognitive Therapy is a trainer-assisted course based on the manual for Mindfulness-Based Cognitive Therapy for depression. The course consists of 8 modules, one per week, for 8 weeks and one additional week for flexibility for the participants. In total 9 weeks with weekly written contact to the personal instructor.

Each module has an overall theme with written theory, approximately 45 minutes of daily mindfulness practice and other daily assignments with the purpose of strengthening awareness in the everyday life.

Internet-delivered Mindfulness-Based Cognitive Therapy

Participants in the control arm of the study will receive treatment as usual, which means that they are not offered interventions targeting psycho-social distress but also not prevented from participating in or seeking other psycho-social treatment during the course of the study.

After the 6-months follow-up time has passed participants will get the opportunity to participate in 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy, if the intervention is found efficient.

Eva R Nissen, MSc

AIM: The aim of the present study is to investigate if Internet-delivered Mindfulness-Based Cognitive Therapy (I-MBCT) can reduce symptoms of depression and anxiety among women treated for breast cancer and men treated for prostate cancer compared to a treatment as usual control group. Furthermore, the effect of I-MBCT on symptoms of stress, insomnia, quality of life, and self-compassion and the potential mediating effect of working alliance and mindfulness will be explored. Finally, the cost-effectiveness of the I-MBCT intervention will be explored.

BACKGROUND: Symptoms of depression, anxiety, and stress are prevalent late-effects among cancer patients and -survivors. Mindfulness-based interventions aim at improving affect tolerance and emotion regulation, which could be of particular relevance for cancer patients and survivors, and MBCT has been shown efficacious in treating symptoms of depression, anxiety, and stress among cancer patients and survivors. However, the availability of face-to-face delivered MBCT is limited and hence using the internet to deliver MBCT may be a cost-effective way of increasing the accessibility of the intervention to vulnerable patients with limited resources.

METHODS: A total of 155 participants will be recruited from Department of Oncology and Department of Urology at Aarhus University Hospital and randomized to two groups: I-MBCT and a treatment-as-usual wait-list control group. Assessments will be conducted at pre-, midway and post intervention and at a 6- months follow-up.

BACKGROUND

Symptoms of depression, anxiety, and stress is common among both cancer patients and cancer survivors and can lead to prolonged hospitalization, reduced quality of life, and deteriorate prognosis. In Mindfulness-Based Cognitive Therapy (MBCT) participants practice attention towards the present moment and acceptance of feelings and physical discomfort. This is in particular relevant for cancer patients and -survivors who often experience psychological symptoms connected to negative thoughts about the past and worries about the future.

MBCT is an 8-week group intervention and has shown to be effective in treating psychological distress in cancer survivors. Many cancer survivors experience challenges in following a group intervention because of health related reduced mobility and work- and family schedule conflicts, and hence it is relevant to investigate an internet-delivered alternative to MBCT.

I-MBCT is a manualized treatment for breast- and prostate cancer survivors, based on the manual for Mindfulness-Based Cognitive Therapy for depression. I-MBCT consist of 8 weeks of mindfulness practice combined with reading theory and supported by weekly text messages and answers from a therapist.

AIMS AND HYPOTHESES

In a randomized controlled trial the efficacy of 8-weeks I-MBCT for breast- and prostate cancer survivors will be investigated.

1. The primary aim of the study is to investigate if Internet-delivered Mindfulness-Based Cognitive Therapy (I-MBCT) will reduce symptoms of depression and anxiety among women treated for breast cancer and men treated for prostate cancer and that the effect is remained at 6 months after the treatment.
2. The secondary aim is to explore the effect of I-MBCT on symptoms of stress, insomnia, and quality of life.
3. Furthermore, the study aims to explore the potential mediating effect of working alliance, self-compassion, and mindfulness.
4. Finally, the cost-effectiveness of the I-MBCT intervention will be explored.

PARTICIPANTS AND PROCEDURES

A total of 155 breast- and prostate cancer survivors are consecutively recruited from Aarhus University Hospital, Denmark. Staff at the Outpatient Clinics at Department of Oncology and Department of Urology will screen patients for psychological distress at follow-up check-ups. If the patients indicates a moderate to high level of psychological distress, further information about the project will be given and patients can sign up for study enrollment.

Participants will after initial screening receive a phone call from a project staff to clarify if inclusion criteria are met. After informed consent all participants will fill out the online baseline questionnaire and then be randomized to either I-MBCT or a wait-list control group receiving treatment as usual in a ratio of 7:3 by means of a computer-generated randomization list.

Participants fill out online questionnaires at baseline, midway (after 5 weeks), post treatment (after 10 weeks) and at follow-up after 6 months.

The intervention group receive the 8-weeks of therapist-assisted I-MBCT which contains assessment of the Therapeutic Alliance at 2, 4, and 7 weeks after treatment onset.

The statistical evaluation of the effect I-MBCT compared to the waitlist control will be performed with Multilevel Linear Models and post-hoc tests. The possible mediating effects will be evaluated using Preacher \& Hayes bootstrapping method. All analyses will be performed with a two-sided significance level of .05.

REGISTRATION DETAILS

The study record reported in ClinicalTrials.gov is completely consistent with the protocol approved by the Central Region Denmark Committee on Health Research Ethics before enrollment start. The study was registered in ClinicalTrials.gov after enrollment had started but before any data analysis was initiated.

After baseline assessment, participants will be randomly assigned to either the intervention or the control group. Both groups will receive online questionnaires at 5 weeks (midway), 10 weeks (post treatment) and 36 weeks (6 months follow-up) after baseline assessment.

The intervention group receives a therapist phone call prior to enrollment in the internet-delivered treatment and then participates in 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy. The internet-delivered treatment also comprises weekly distress measures, including suicide risk screening, and assessment of working alliance at week 2, 4, and 7 of the course.

Assessors performing introduction calls are masked in the sense that participants will not be randomized until after the introduction call. All questionnaires are completed as online surveys and are hence masked for group allocation.

Online Mindfulness for Women Treated for Breast Cancer and Men Treated for Prostate Cancer

Internet-delivered Mindfulness-Based Cognitive Therapy for Symptoms of Depression, Anxiety, and Stress Among Women Treated for Breast Cancer and Men Treated for Prostate Cancer - Effects and Mechanisms

Change in symptoms of insomnia assessed by Insomnia Severity Index (ISI)

Change in Self-compassion assessed by The Self-Compassion Scale (SCS)

Change in Quality of Life assessed by the World Health Organization Well-being index (WHO-5)

Change in symptoms of depression assessed by Beck Depression Inventory II (BDI-II)

Change in symptoms of anxiety assessed by State-Trait Anxiety Inventory Form Y (STAI-S)

Change in symptoms of stress assessed by the Perceived Stress Scale (PSS)

Change in The Short Form Health Survey (SF-12+)

Aarhus University Hospital

Karolinska Institutet

Region Stockholm

University of Aarhus

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Quality of Life

Lymphosarcoma

Participants randomized to the intervention group will be allocated a pre-registered Fitbit, a personalized exercise prescription designed by the kinesiologist, and 12 weeks of supervision by the kinesiologist.

Participants will receive the exact same Lymfit exercise intervention 3 months after they consent to participate in the study.

Participants randomized to this arm will be allocated a pre-registered Inspire II / Charge IV model Fitbit. The kinesiologist of the study will meet with the participants for a baseline fitness assessment. The kinesiologist will examine the baseline physical activity levels, fitness level and sedentary behaviours of the participants, to design a personalized exercise prescription. Within one week after the baseline fitness assessment, the kinesiologist will contact the participants to discuss the exercise prescription. Every two weeks there-after, the kinesiologist will follow up with the participants via videoconferencing to discuss their progress and to modify or advance their exercise prescriptions as needed. Participants will be followed-up at 6 months and 12 months.

Lymfit exercise intervention

Participants will be contacted by the study kinesiologist for a baseline fitness assessment 3 months after they consent, participants will be given a Fitbit, a personalized exercise prescription and receive bi-weekly follow-ups for 12 weeks.

Christine Maheu, Ph.D.

Christine Maheu

This randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors.

Lymphoma is the most common cancer diagnosed in young adults. While curing 80% of patients, lymphoma treatment has a significant impact on young adults' health and psycho-social wellbeing by increasing fatigue and anxiety, risk of cardiovascular disease and other chronic disorders, all of which compromise one's quality of life. Regular exercise has the potential to reduce the side effects associated with cancer treatments. Thus, the most recent guidelines suggest that cancer patients should engage in adapted exercise programs during and after their treatment.

However, these guidelines are not systematically recommended by doctors and are often not followed by patients. Fatigue and lack of motivation are the main barriers to exercise among cancer survivors. Our study aims to identify young adults lymphoma patients and encourage them to adhere to the exercise guidelines with the help of an exercise physiologist and a fitness tracker. The investigators will evaluate the efficacy of these strategies in motivating exercise among young adults lymphoma survivors. Our proposed study carries significant implications for the prevention of complications of treatment for young adults lymphoma survivors.

Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors

Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors: A Randomized Controlled Trial

The investigators will determine the percentage of lymphoma patients who adhere to the recommended exercise guidelines for cancer patients at baseline and after the intervention, i.e. compare the minutes of Moderate to vigorous physical activity per week captured in the Fitbit among participants in the intervention arm and waitlist control arm at baseline and 3 months.

The Patient-Reported Outcomes Measurement Information System-29 is a 29-item instrument assessing multi-dimensional eight domains (29 items) (i.e., anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities, and pain intensity). Raw scores generated for each domain are transformed into T scores; higher T scores indicate greater endorsement of the construct being assessed.

The Work Ability Index (WAI) questionnaire (7 items) will be used to collect productivity loss data within clinical trials and is suitable for direct translation into a monetary figure. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor \[7-27\], moderate \[28-36\], good (37-43) and excellent (44-49).

Cancer Worry Scale is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The scale consists of six questions with four response options (1 = not at all or rarely; 2 = sometimes; 3 = often; 4 = almost all the time), such that each individual attains a score ranging from 6 (minimum worry) to 24 (maximum worry).

Jewish General Hospital

McGill University Health Centre/Research Institute of the McGill University Health Centre

McGill University

Associate Professor

6 consecutive improvisational comedy classes

Improvisational comedy classes

After 10 week waitlist control, subjects will complete 6 consecutive improvisational comedy classes.

Arash Asher, MD

This is a 2-arm randomized waitlist controlled trial. A total of 46 of subjects are planned. Subjects will be assigned to the intervention vs. waitlist control group in a randomized fashion. All subjects will complete baseline assessments prior to randomization. Baseline assessments will be completed within two weeks before the start of the improv series. Subjects in the intervention group will complete 6 consecutive improv classes. Patients in the control group will be permitted to complete the improv course (within 10-12 weeks) and follow-up after their 10 week control timeline is complete. Evaluations for the intervention group will be taken at baseline (T0), the last day of class (T1), one month after the last day of class (T2), and 6 months after the last day of class (T3). Evaluations for the waitlist control group will be taken at baseline #1 (T0), 6 weeks after T0 (T1), one month after T1 (T2), first day of class (Baseline 2, T0b), last day of class (T1b), one month after the last day of class (T2b), and 6 months after the last day of class (T3b). Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

Total duration of the study is expected to be 2 years.

LOL: It's All Improv After Cancer!™

IIT2018-05-ASHER-IMPROV2 - LOL: It's All Improv After Cancer!™ - A Randomized Clinical Trial Examining the Impact of an Improvisational Comedy Intervention on Well-Being Among Patients With Cancer

Change of the Functional Assessment of Cancer Therapy - General (FACT-G) score between the intervention and control groups. Total scores range from 0-108, with higher scores representing better outcomes.

Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress - Anxiety - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with lower scores representing better outcomes.

Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress - Depression - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with lower scores representing better outcomes.

Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Social Isolation score between the intervention and control groups. Total scores range from 14-70, with lower scores representing better outcomes.

Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) General Self-Efficacy score between the intervention and control groups. Total scores range from 10-50, with higher scores representing better outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues	NCT05540392	Survivorship Prostate Cancer	Acupuncture Waitlist Contro... Questionnaires	18 Years -	Memorial Sloan Kettering Cancer Center
Memory Training Intervention for Breast Cancer Survivors	NCT01497015	Breast Cancer	memory training speed of proces... waitlist contro...	40 Years -	Indiana University
A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors	NCT03768336	Cancer	Waitlist contro... 3RP-AYA	16 Years - 29 Years	Massachusetts General Hospital
A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors	NCT03768336	Cancer	Waitlist contro... 3RP-AYA	16 Years - 29 Years	Massachusetts General Hospital
Mammography and Breast Arterial Calcification: An Information-Sharing Trial	NCT04983875	Mammography Vascular Calcif...	BAC-Enhanced Le... Waitlist Contro...	40 Years -	Icahn School of Medicine at Mount Sinai
Online Mindfulness for Women Treated for Breast Cancer and Men Treated for Prostate Cancer	NCT03100981	Anxiety Depress... Breast Cancer F... Prostate Cancer	Internet-delive... Waitlist contro...	18 Years -	University of Aarhus
Memory Training Intervention for Breast Cancer Survivors	NCT01497015	Breast Cancer	memory training speed of proces... waitlist contro...	40 Years -	Indiana University
Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors	NCT05257785	Lymphoma Cancer Survivor...	Lymfit exercise... Waitlist contro...	18 Years - 39 Years	McGill University
LOL: It's All Improv After Cancer!™	NCT03824132	Breast Cancer Psychological D...	Improvisational... Waitlist contro...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for waitlist control