Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Participants will be randomly assigned to the Exercise Group (PARE) and will complete study procedures as outlined:

* 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance equipment, heart-rate monitor, and a wi-fi enabled tablet.
* Clinic visits at week 1, week 10, and 30 days post Autologous Stem Cell Transplantation (ASCT).
* Questionnaires and surveys.

Participants will be randomly assigned to the Waitlist Control Group and will complete study procedures as outlined:

* 8 weeks of continuing with normal daily activities.
* Option to participate in PARE exercise program after study completion.
* 3 clinic visits with option of 5 visits. The two additional visits are for evaluation and testing for those who choose to participate in exercise program after study completion.

Aerobic and resistance exercise program via Zoom platform.

PARE

Waitlist Control Group

Christina Dieli-Conwright, PhD, MPH

Christina Dieli-Conwright, PhD

Christina Dieli-Conwright

The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program implemented 8 weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma participants will improve muscular strength, physical capacity, patient reported outcomes, and cardiometabolic health outcomes.

The names of the study interventions involved in this study are:

* Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week aerobic and resistance exercise program)
* Waitlist control (8-week normal activity behavior)

This is a single-center, prospective, parallel-group, randomized controlled study that will enroll patients diagnosed with multiple myeloma planning to receive autologous stem cell transplant (ASCT).

Participants will be randomized into one of the intervention groups: Exercise Group (PARE) versus Waitlist Control Group. Randomization means that participants are placed into one of the treatment groups by chance.

The research study procedures include screening for eligibility and study treatment including evaluations of muscle strength, cardiorespiratory fitness, physical fitness assessments, body composition including DEXA scans, blood tests, and surveys at study entry and follow-up visits.

Participation is expected to last about 4 months for the Exercise Group (PARE) and 9 months for the Waitlist Control Group.

It is expected about 30 people with take part in this research study.

Dana-Farber Cancer Institute is supporting this research study by providing funding through the Population Sciences Team Science Concept program.

Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

The primary analysis is a mean difference in percent change between the intervention (PARE) and the control (Waitlist) groups in lower leg muscle strength measured through leg press.

Physical capacity includes physical function and cardiorespiratory fitness which are measured through the Short Physical Performance Battery (SPPB) protocol and a maximal oxygen uptake (VO2 max) test, respectively. Differences in physical capacity across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.

Patient reported outcomes, including fatigue and quality of life, are assessed through validated questionnaires. Differences in patient reported outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.

Cardiometabolic health outcomes, including biomarkers of metabolic syndrome and body composition will be assessed through blood draws and dual-energy X-ray absorptiometry (DEXA), validated and safe measures. Differences in cardiometabolic health outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.

Dana-Farber Cancer Institute

Principal Investigator

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

3 sessions of yoga each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

3 sessions of stretching each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

Option of participating in the yoga or stretching program after the study has ended. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

3 sessions of yoga each week for 6 weeks.

Yoga Group

3 sessions of stretching each week for 6 weeks

Stretching Control Group

Option of participating in the yoga or stretching program after the study has ended.

Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

Questionnaire

Lorenzo Cohen, PhD

In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective.

Our specific aims in the proposed study are to:

* Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality.
* Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability).
* Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.

If you choose to take part in this study, you will come to M. D. Anderson for your first visit. If this is not convenient, a researcher can visit you at your home. At this time, you will be asked to complete several questionnaires. The questions will ask about your sleeping habits, how you have been feeling, and your general QOL. This will take about 45-60 minutes to complete. Researchers, will then ask you to complete a daily sleep diary for the next 7 days. During this time, you will be given an actigraph watch to wear that will collect data about your day-time activity and sleeping habits. The watch should be worn 24 hours a day for 7 days a week. You will have an electrocardiogram (ECG - a test to measure the electrical activity of your heart) and your breathing rate will be measured.

After your first visit to M. D. Anderson or after a researcher has visited you at home, you will be randomly assigned (as in the toss of a coin) to one of 3 groups.

Participants in the first group will take part in a yoga program. If you are assigned to the yoga group, you will take part in 3 sessions of yoga each week for 6 weeks. You may take part in the yoga sessions any 3 days of the week. Each yoga session will last around 60 minutes. During the yoga sessions, you will also be asked to do breathing exercises and to perform different movements and meditation. None of the movements are difficult. You will be able to follow this program at your own pace.

Participants in the second group will take part in a stretching program. If you are assigned to the stretching group, you will take part in 3 sessions of stretching each week for 6 weeks. You may take part in the stretching sessions any 3 days of the week. Each stretching session will last around 60 minutes. During these stretching sessions you will be asked to do simple stretching exercises. None of the movements are difficult. You will be able to follow this program at your own pace.

Beginning with the second week, participants in the first and second groups will be asked to complete a brief questionnaire, about the yoga or stretching program, before the first class each week. The questionnaire will take about 1 to 2 minutes to complete. You will also have an ECG and your breathing rate will be measured before and after one of the classes during the third or fourth week and again during the last week. Each stretching and yoga session will be audio and video taped for the purpose of quality control.

Participants in the third group will not take part in the yoga or stretching program during this study. However, if you are assigned to this group, you will be given the option of participating in the yoga or stretching program after the study has ended. This will be after you have finished your last assessment.

All participants will complete a brief questionnaire during the middle of radiotherapy. The questionnaire will evaluate your treatment-related symptoms and will take about 15 minutes to complete.

During the last week of radiotherapy, and at 1, 3, and 6 months after the end of radiation treatment, all participants will be asked to fill out a packet of questionnaires (similar to those taken at the first visit). It should take about 45 minutes to complete all of the questionnaires. If it is not convenient for you to come to M. D. Anderson, a researcher can visit you at home to help with the questionnaires. You will then be asked to complete another daily sleep diary for another 7 days. During this time, you will wear an actigraph watch 24 hours a day for 7 days a week to collect the same data as before. During this time, you will have an ECG and your breathing rate will be measured.

All participants will be asked to refrain from participating in any other yoga classes for the duration of the study.

Your participation in this study will be over after your 6-month assessment.

This is an investigational study. Up to 180 patients will take part in this study. All will be enrolled at M. D. Anderson.

Effects of Yoga in Breast Cancer Patients

Biobehavioral Effects of Yoga During Breast Cancer Treatment

National Institutes of Health (NIH)

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Depressive Disorder

Depression

Pain

Carcinoma

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Neoplasms, Glandular and Epithelial

A 6- week ACT intervention for depression and physical pain will be delivered.

The WL control group will receive treatment as usual, just like women in the experimental condition.

The ACT-based intervention will be delivered in a group format. Due to the COVID-19 pandemic and given that breast cancer patients are considered a vulnerable population, the intervention will be administered online through a GDPR compliant platform. The six, weekly, 90-minute treatment sessions (total of 9 hours) will be conducted in groups of approximately 8-10 participants and one therapist.

Acceptance and Commitment Therapy

Participants randomized to the WL condition will be asked to continue receiving the services they receive from anti-cancer associations (receiving care from nurses, or/and support from social workers, or/and physiotherapy or/and individual psychological support from licensed psychologists just like the women in the experimental condition).

Maria Karekla, Ph.D.

Marianna Zacharia, M.Sc.

Maria Karekla, PhD

As a result of the cancer diagnosis and medical therapies, women with breast cancer often encounter debilitating cooccurring psychological and physical symptoms. While pain constitutes one of the most common adverse physical side effects of medical treatment reported by breast cancer patients, the most prevalent psychological symptom they seek psychological help for is depressive symptoms. Acceptance and Commitment Therapy (ACT) in psychosocial oncology care may be particularly beneficial in targeting depression and cancer-related pain. The aim of the I-CAN-ACT project is to examine in a RCT the efficacy of a brief ACT-based intervention for both depression and physical pain (6 online sessions) compared to a waitlist control on various outcomes in women with breast cancer. Outcomes will include quality of life, physical pain intensity and interference, depression, and anxiety in women with breast cancer. These will be assessed at post-treatment and at the 1-month, 3-month, 6-month and 1 year follow-ups (for Marianna Zacharia's PhD thesis, results will be presented until the 3-month follow-up). Also, the Acceptability and Feasibility of the intervention will be assessed. That is, participants' treatment acceptability and adherence to the brief ACT intervention in terms of retention, treatment engagement and satisfaction with each session and with the overall treatment will be assessed. Participants' reasons for dropout will be recorded.

As a result of the cancer diagnosis and medical therapies, women with breast cancer often encounter debilitating cooccurring psychological and physical symptoms. While pain constitutes one of the most common adverse physical side effects of medical treatment reported by breast cancer patients, the most prevalent psychological symptom they seek psychological help for is depressive symptoms. Acceptance and Commitment Therapy (ACT) in psychosocial oncology care may be particularly beneficial in targeting depression and cancer-related pain. The aim of the I-CAN-ACT project is to examine in a RCT the efficacy of a brief ACT-based intervention for both depression and physical pain (6 online sessions) compared to a waitlist control on various outcomes in women with breast cancer.

Based on preliminary empirical findings, the hypotheses of this study are:

1. The group ACT-based intervention will demonstrate significantly greater improvements in the primary outcome (quality of life: physical well-being, emotional well-being, social/family well-being, functional well-being, additional concerns for breast cancer) compared to the WL at post-treatment, at 1-month and 3-month follow-ups.
2. The group ACT-based intervention will demonstrate significantly greater reductions in the secondary outcomes (pain intensity and interference, depression and anxiety) compared to the WL at post-treatment, at 1-month and 3-month follow-ups.
3. The group ACT-based intervention will present significant improvements in the ACT components (acceptance, cognitive defusion, contact with the present moment, self-as-context, self-compassion, values clarification, committed action) compared to the WL at post-treatment, at 1-month and 3-month follow-ups.
4. It is hypothesized that the mechanisms/core processes, via which ACT is expected to exert its effects, will mediate pre to 1-month follow-up and pre to 3-month follow-up quality of life scores (primary outcome) for the ACT-based intervention.
5. It is hypothesized that the mechanisms/core processes, via which ACT is expected to exert its effects, will mediate pre to 1-month follow-up and pre to 3-month follow-up scores of secondary outcomes (physical pain intensity and interference, depression, anxiety).
6. Completing any ACT skill in a session will lead to improvement in that specific skill (ACT proposed mechanism of action) in-the-moment within each week of the group ACT-based intervention.

This is the first study to:

i. examine the longitudinal effects (1-month and 3-month follow ups) of an ACT intervention on both depression and physical pain, which often co-occur in female breast cancer patients ii. examine all the processes of change in ACT responsible for effective treatment outcomes in women with breast cancer iii. offer a brief ACT intervention for this population iv. assess participants' treatment acceptability and adherence to an ACT-based intervention in terms of retention, treatment engagement and satisfaction with treatment for this population v. assess therapists' fidelity/adherence to the protocol and the ACT approach as well as the therapists' competence, when implementing a RCT for women with breast cancer vi. employ the innovative methodological approach of Ecological Momentary Assessment through a mobile application in addition to standardized pre post-follow-up self-report questionnaires to assess changes in the ACT processes as a result of intervention

A 2-arm RCT will be conducted (brief ACT-based intervention vs waitlist control group).

An Intervention for Female Breast CANcer: Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain

Efficacy of a Brief Intervention for Female Breast CANcer Based on Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain: A 2-Arm Randomized Clinical Trial

Therapists' ACT-consistent and ACT-inconsistent responses and behaviors will be assessed using the ACT Fidelity Measure (ACT-FM; O'Neill, Latchford, McCracken, \& Graham, 2019). ACT-FM is a 25-item scale, which captures four important areas within ACT: Therapist Stance, Open Response Style, Aware Response Style and Engaged Response Style. The items are scored to measure the therapist's behaviors as consistent and inconsistent with these four areas. Items are rated on a range of 0 when the behavior did not occur to 3 when the behavior occurred extensively. Higher scores are assigned when the behavior occurs more consistently. A Total ACT Consistency Score (0-36) and a Total ACT Inconsistency Score (0-36) will be calculated for each session.

The Session Rating Scale Version 3 is used on a session by session basis to assess the working alliance (SRS V.3; Duncan et al., 2003). The SRS V.3 entails four 10-cm visual analog scales, where participants are required to make a hash mark on a continuum line, which on the left represents the least satisfaction, and on the right represents the most satisfaction.

Overall participants' acceptability and adherence to treatment will be assessed with the Treatment Acceptability/Adherence Scale (TAAS; Milosevic, Levy, Alcolado, \& Radomsky, 2015), a 10-item self-report scale. The scale is rated on a 7-point Likert scale, ranging from 1 "Disagree strongly" to 7 "Agree strongly". Six items are reversed when scoring (3, 4, 5, 7, 8 and 10) and scores may range from 10 to 70. Higher scores represent greater acceptability of treatment and greater ability to adhere to it.

It consists of five well-being domains: physical well-being (7 items), emotional well-being (6 items), social/family well-being (7 items) and functional well-being (7 items), which constitute the Functional Assessment of Cancer Therapy - General (FACT-G; Cella et al., 1993) and the additional concerns for breast cancer, the Breast Cancer Subscale (BCS; 10 items). Each item on the FACT-B is rated on a five-point scale ranging from 0 = "not at all" to 4 = "very much". The total score can range from 0 to 144 and is the sum of scores from all five subscales. Higher scores reveal greater perceived quality of life.

It is a 14-item self-report measure of psychological distress in individuals with physical health problems (Johnston, Pollard, \& Hennessey, 2000; Roberts, Bonnici, Mackinnon, \& Worcester, 2001). Scale scores are thought to be unbiased by the existence of bodily illness (Zigmond \& Snaith, 1983). HADS assesses anxiety (7 items) and depression (7 items) independently, rated on a four-point scale (range= 0-3; different anchors per item), with scores ranging between 0 and 21 per subscale. Higher scores indicate higher levels of anxiety and depression.

It was initially developed in English in the USA (Cleeland, 1989) and has been validated in several languages. The Greek Brief Pain Inventory- Short Form (G-BPI; Mystakidou et al., 2001) is a 9-item self-report questionnaire used to assess pain intensity and pain interference in cancer patients. Patients are requested to rate their worst, least, average and current pain intensity and report current medications/treatment along with their perceived effectiveness on a 10-point scale, ranging from 0 = "no pain" to 10 = "pain as bad as you can imagine". Also, they are asked to rate the extent to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life on a 10-point scale, ranging from 0 = "does not interfere" to 10 = "completely interferes". Higher scores indicate higher pain intensity and higher pain interference.

The PsyFlex (Gloster et al., 2021) is an 8-item self-report measure that assesses all six processes/skills of the ACT Hexaflex; that is psychological flexibility. Items of the PsyFlex are rated on a 5-point Likert type scale, ranging from 1 "very often" to 5 "very rarely". Higher scores indicate lower levels of psychological flexibility.

The Greek Acceptance and Action Questionnaire - II (AAQ-II; Greek version: Karekla \& Michaelides, 2017; English version: Bond et al., 2011) is a 7-item self-report measure of experiential avoidance or its reverse, psychological flexibility. Items are rated on a 7-point Likert scale, ranging from 1 = "never true" to 7 = "always true". Higher scores indicate greater experiential avoidance while lower scores indicate greater psychological flexibility.

The Cognitive Fusion Questionnaire (CFQ; Greek version: Zacharia et al., 2021; English version: Gillanders et al., 2014) is a brief, 7-item self-report scale of cognitive fusion. Items are rated on a 7-point Likert scale (range from 1 = "Never true" to 7 = "Always true". Higher scores indicate higher levels of cognitive fusion.

The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman, Hayes, Kumar, Greeson, \& Laurenceau, 2007) is a 12-item self-report measure of mindfulness, designed based on the definition of mindfulness as "the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment to moment" (Kabat-Zinn, 2003, p. 145). Items are rated on a 4-point Likert scale, ranging from 1 "rarely/not at all" to 4 "almost always". Authors suggest the use of a total score.

The Self-as-Context Scale (SACS; Zettle et al., 2018) is a brief (10-item) self-report scale of contextual self. Items are rated on a 7-point Likert scale, ranging from 1 "Strongly disagree" to 7 "Strongly Agree". Higher scores indicate higher levels of Centering, Transcending and Contextual Self.

The Valuing Questionnaire (VQ; Smout, Davies, Burns, \& Christie, 2014) is a 10-item measure that assesses the degree to which the person lives and acts in accordance to his/her values. Items are rated on a 7-point Likert type scale, ranging from 0 "never true" to 6 "always true".

Committed Action Questionnaire (CAQ; McCracken et al., 2015), is an 8-item scale that examines goal-directed behaviors. Items are rated on a 7-point Likert-type scale, ranging from 0 "never true" to 6 "always true". Negatively worded items are reverse scored in order to indicate higher levels of committed actions. Higher scores indicate a higher tendency to persist in value-driven actions.

The Self-Compassion Scale (SCS; English version: Neff, 2003; Greek version: Mantzios, Wilson, \& Giannou, 2015) is a 26-item scale that measures six constituents of self-compassion. Items are rated on a 5-point Likert-type scale, ranging from "Almost Never" to "Almost Always". A total self-compassion score is calculated after reversing the negative subscale items and adding all subscale scores. Higher scores indicate higher self-compassion.

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue (EORTC QLQ-FA12, abbreviated as FA12) will be used as a measure of cancer related fatigue (Weis et al., 2017). It is comprised of 12 items, with four response categories for each item, coded with values from 1 to 4. Higher scores indicate greater fatigue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation	NCT05706766	Multiple Myelom... Stem Cell Trans...	PARE Waitlist Contro...	18 Years -	Dana-Farber Cancer Institute
Effects of Yoga in Breast Cancer Patients	NCT00508794	Breast Cancer	Yoga Group Stretching Cont... Waitlist Contro... Questionnaire	18 Years -	M.D. Anderson Cancer Center
An Intervention for Female Breast CANcer: Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain	NCT05374161	Female Breast C... Depression Pain	Acceptance and ... Waitlist Contro...	18 Years - 99 Years	University of Cyprus

Spots Global Cancer Trial Database for waitlist control group