Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Fatigue

All Drugs and Chemicals

Tin Fluorides

Women received psychological rehabilitation

Women received routine health education in the unit

A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. women practiced seated exercises

Seated Exercises

Women received Psycho-educational Rehabilitation, including mindfulness breathing, problem-solving training, cognitive re-framing technique, and thought stopping.

Psychoeducational Rehabilitation

Women received routine health education in the unit, where nurses provided general instructions about the postoperative activities for women with breast cancer.

Routine Care

Eman Taha, Professor

This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.

Hypotheses for research:

1. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.
2. Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.

A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping.

A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions.

Researchers prepared a health education unit and designed a booklet about seated exercises and psychological interventions. The developed program was applied to each patients using teach-back method.

Seated Exercises In the sitting position, women were instructed to perform different types of exercises. Researchers demonstrated each exercise and asked women to practice preoperatively to be ready for re-demonstrating them after surgery. Patients were asked to perform the exercise repeatedly until mastering the necessary skills.

Psychological Rehabilitation The participants received training about the implementation of four psychological interventions, namely mindfulness breathing, problem-solving training, cognitive reframing, and thought stopping.

Follow-up Women were instructed to practice each exercise ten times and repeat the whole activity five times per day. Women were followed up for two months to ensure their commitment to the program and provide the needed support.

Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy

Empowering Mind-Body Wellness: Effect of Bundling Seated Exercises and Psychoeducational Rehabilitation Using the Teach-Back Approach on Fatigue and Coping of Women Postmastectomy

The scale was developed to measure the subjective dimension of fatigue. It include 22 items measuring four elements of subjective fatigue: behavioral/temporal (6 items), sensory (5 items), cognitive/mood (6 items), and affective/emotional meaning (5 items). Participants were asked to rate their level of fatigue on a scale ranging from 0 to 10. The total score ranges from 0 to 220; the higher the score, the higher the fatigue level

This self-report survey created to gauge the cancer patients' ways to cope. It consists of 29 items rated on a four-point Likert scale ranging from 1 "Does not apply at all to me" to 4 "Totally applies to me"). It includes five subscales under two main categories: maladaptive coping, including helplessness/hopelessness (8 items), and anxious preoccupation (8 items). The higher the score, the higher the maladaptive coping. However, adaptive coping includes fighting spirit (4 items), fatalism (5 items), and cognitive avoidance (4 items) . In this category, high scores means increased the likelihood of adaptive coping skills.

Alexandria University

Assisstant Profesor

Recurrence

Disease Attributes

Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills.

Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community.

IN FOCUS

Usual Care

Daniel L Hall, PhD

The purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (FOR) among cancer survivors.

This is a randomized pilot feasibility trial (1:1 intervention versus usual care; a referral to community-based cancer survivor support group) that will use mixed methods (quantitative and qualitative) to evaluate the feasibility, acceptability, and preliminary effects of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (IN FOCUS) among cancer survivors with clinically elevated fear of recurrence (N = approximately 64).

Patient-reported outcomes on psychological and behavioral outcomes will be measured at T0 (baseline), T1 (post-intervention/approximately two months post-baseline), and T2 (three months post-intervention/approximately five months post-baseline). Exit interviews will be conducted after the T1 survey. Participants are expected to be in the study for approximately five months.

Mind-body Resiliency Intervention for Fear of Cancer Recurrence

IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors

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: Daniel L. Hall, PhD (hall@mgh.harvard.edu). 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 metric for assessing feasibility will be retention at the initial follow-up assessment (≥70% survey completion). For descriptive purposes, secondary exploratory metrics of feasibility will include reasons for ineligibility, refusal, or dropping out will be measured, as will rates of enrollment, ratio of screened-to-eligible, attendance (e.g., ≥75% of intervention sessions attended), self-reported adherence to relaxation skills practice, and interventionist fidelity. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions.

As a primary quantitative acceptability outcome, participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the intervention.

Fear of cancer recurrence (FCR) severity will be measured using the 9-item Fear of Cancer Recurrence Inventory severity subscale. Scores range from 0-36 with higher scores indicating greater FCR severity. To supplement this measure, open-ended questions in the exit interview will assess perceived changes in FCR.

Resiliency will be measured using the 23-item Current Experiences Scale. Subscale scores and total scores (range from 0-115) will be computed, with higher scores indicating higher resiliency.

National Center for Complementary and Integrative Health (NCCIH)

Massachusetts General Hospital

Principal Investigator

Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills.

IN FOCUS: Adapted Resiliency Group Intervention

Intervention (IN FOCUS)

Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community.

Usual Care: Referral to Virtual Group Support

Total

Age, Continuous

Sex: Female, Male

Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Other

Hispanic

Participants could be included in more than one Race/Ethnicity category/row.

Race/Ethnicity, Customized

All participants who consented and completed the baseline survey

Dr. Daniel Hall

Feasibility: Retention Rate

Enjoyableness

Convenience

Helpfulness

Odds of Future Skills Use

Overall Satisfaction

IN FOCUS participants who responded to the acceptability measure.

Acceptability Items

This acceptability metric was assessed within the intervention arm only.

Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction

Baseline

2 Months

5 Months

Fear of Cancer Recurrence

Resiliency

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

Poly(ADP-ribose) Polymerase Inhibitors

Recruit up to 5 patients who meet eligibility criteria to participate in the run-in period of the study

* Participants will receive a 6-week Acceptance and Commitment Therapy (ACT) intervention (REVITALIZE).

Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.

Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.

Enhanced Usual Care (EOC)

Six 60-75 minute telehealth sessions approximately once a week for 6-8 weeks

REVITALIZE ACT Intervention

Alexi A Wright, MD, MPH

This study is testing whether a 6 week skills-based telehealth intervention can help ovarian cancer patients experiencing PARP inhibitor-related fatigue reduce the impact of fatigue on their daily life and activities.

This is a two-arm, multicenter pilot randomized controlled trial to compare the feasibility, acceptability, and preliminary efficacy of REVITALIZE, a 6-week Acceptance and Commitment Therapy (ACT) telehealth intervention vs. enhanced usual care (EUC) in fatigued patients with ovarian cancer on maintenance PARPi.

The intervention is called REVITALIZE, and it is a structured, skills-based intervention for providing support, knowledge, and skills for coping with fatigue. This type of intervention has been used in other studies to treat symptoms such as pain, migraines, or worry. This research is being done to develop this program at the Dana-Farber Cancer Institute and the University of Pennsylvania's Abramson Cancer Center, and to get patient feedback on the telehealth intervention to improve it for a future study. The study is also making a preliminary determinations as to whether REVITALIZE does improve psychological flexibility and fatigue-related interference and reduce fatigue, psychological distress, and fear of cancer recurrence, while improving overall quality of life (QOL).

The study will pre-pilot the REVITALIZE intervention in up to 5 patients at the Dana-Farber Cancer Institute (DFCI). This run-in phase serves to test and refine the newly developed 6-week ACT intervention in a smaller sample size prior to initiating the randomized control trial (RCT) portion of the study. After the ACT intervention has been tested and refined, the study will enroll and randomize 40 fatigued patients with advanced ovarian cancer on maintenance PARPi at Dana-Farber Cancer Institute and the Abramson Cancer Center at the University of Pennsylvania.

Participants will be randomized to receive either a 6-week ACT intervention or enhanced usual care (educational materials). The study anticipates enrolling approximately 20 patients at each site, and 20 patients will be enrolled to each study arm.

It is expected participants will remain in the study for the duration of the intervention and follow-up assessments, which is approximately 3 months.

The Funding Organization for this study is the National Comprehensive Cancer Network (NCCN) and the Research Funding Provider is AstraZeneca.

REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue

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

Feasibility will be defined as ≥50% approach-to-enrollment rate of participants eligible participants and ≥70% completion of 3-month outcome assessments.

Acceptability will be defined as ≤20% of participants reporting high study burden and ≤20% withdrawing from the study.

Changes in fatigue will be measured using the Fatigue Symptom Inventory scale, a 14-item, 11-point rating scale developed to assess subjective fatigue, in which higher scores indicate greater fatigue.

Measured by Generalized Anxiety Disorder 7 (GAD-7) scale, a 7-item measure assessing anxiety severity on a 4-point scale (0 = not at all, to 3 = nearly every day). GAD-7 total score for the seven items ranges from 0 to 21. Higher scores indicate more moderate to severe anxiety.

Measured by the Patient Health Questionnaire-8 (PHQ-8) scale, an 8-item measure assessing depression on a 4-point Likert scale (0 = not at all, to 3 = nearly every day). Higher scores indicate more severe depression.

Measured by the 42-item Fear of Cancer Recurrence Inventory (FCRI) scale, which evaluates 7 aspects associated with FCR: 1) triggers, 2) severity, 3) psychological distress), 4) functioning impairments, 5) insight, 6) reassurance, and 7) coping strategies.

Each item is rated on a Likert scale ranging from 0 ('not at all' or 'never) to 4 ('a great deal' or 'all the time'). A total score can be obtained for each subscale, and for the total scale by summing item ratings. Higher scores indicate higher levels of FCR.

Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale.

Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O, scale. Items scored on a 5-point Likert Scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Scores range for each subscale. Higher scores indicate better QOL. Social/family well-being (score range 0-28).

Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale. Items scored on a 5-point Likert Scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Scores range for each subscale. Higher scores indicate better QOL. Emotional well-being (score range 0-28).

Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale. Items scored on a 5-point Likert Scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Scores range for each subscale. Higher scores indicate better QOL. Functional well-being (score range 0-28).

AstraZeneca

National Comprehensive Cancer Network

Dana-Farber Cancer Institute

Behaviors and Mental Disorders

Digestive System Diseases

Anxiety Disorders

Stomach Neoplasms

Depression

Depressive Disorder

Postoperative Complications

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

Stomach Cancer

The investigators would perform the following tests preoperatively on the study subjects.

1. Hospital Anxiety and Depression Scale (HADS)
2. Amsterdam Preoperative Anxiety and Information Scale (APAIS)
3. Coping and Adaptation Processing Scale-Short Form (CAPS-SF)
4. Quality of Recovery -15 (QOR-15)

The investigators plan to evaluate patients' quality of recovery at postoperative day (POD) 1, 2, and 3.

Quality of Recovery -15

Hojin Lee, MD

This study aims to investigate preoperative anxiety, depression, and coping strategy of the patients undergoing laparoscopic gastrectomy for early gastric cancer and their effects on short-term postoperative recovery measured by Quality of Recovery-15 (QOR-15). The findings of the study would improve the perioperative management of early gastric cancer patients.

The researchers plan to investigate preoperative psychological factors such as anxiety, depression, and coping strategy in association with short-term quality of recovery from surgery in 100 patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy).

The following items are investigated before surgery; Age, sex, BMI, level of education, occupation, marital status, ECOG performance status, ASA physical status, Apfel score, history of mental disorder, type of surgery, past surgical history, the number of days from diagnosis of cancer to surgery, clinical stage of cancer, histological type of cancer, presence of chronic pain, Quality of Recovery-15 (QOR-15), Hospital Anxiety and Depression Scale (HADS), Amsterdam Preoperative Anxiety and Information Scale (APAIS), Coping and Adaptation Scale-Short Form (CAPS-SF).

The QOR-15 is investigated for 24, 48, and 72 hours after surgery. The severity of postoperative pain by the 11-point Numerical Rating Scale (NRS) is concurrently measured at 24, 48, and 72 hours after surgery. In addition, the researchers measure postoperative complications, particularly nausea/vomiting, at 24, 48, and 72 hours after surgery and length of stay by counting the number of days from the day of surgery to discharge.

Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery in Early Gastric Cancer

Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery Among Early Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy

There are total 15 items where each of them is an 11-point numerical rating scale (for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items, the scoring was reversed; maximum score 150)

11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"

The number of days that patients spend in the hospital after surgery

Patients' postoperative nausea/vomiting: for each, 0, no; 1 yes, but not severe enough to take antiemetics; 2, yes, severe enough to take antiemetics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy	NCT06360276	Fatigue Coping Behavior	Seated Exercise... Psychoeducation... Routine Care	20 Years - 60 Years	Alexandria University
Mind-body Resiliency Intervention for Fear of Cancer Recurrence	NCT04876599	Cancer Coping Skills Coping Behavior	IN FOCUS Usual Care	18 Years -	Massachusetts General Hospital
REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue	NCT04525183	Ovarian Cancer Fatigue Coping Behavior Coping Skills	Enhanced Usual ... REVITALIZE ACT ...	18 Years -	Dana-Farber Cancer Institute
Effects of Preoperative Anxiety and Depression on Short-term Postoperative Recovery in Early Gastric Cancer	NCT04599231	Postoperative C... Anxiety Depression Coping Behavior	Quality of Reco...	18 Years - 80 Years	Seoul National University Hospital
Mind-body Resiliency Intervention for Fear of Cancer Recurrence	NCT04876599	Cancer Coping Skills Coping Behavior	IN FOCUS Usual Care	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for coping behavior