Session content and timing was developed and confirmed in our qualitative work (Expert Panel) and the CARE pilot study. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).

The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. Five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).

For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).

Cancer and Aging: Reflections for Elders (CARE) Intervention

The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months). Training case participants will follow a slightly condensed schedule.

Social Work and Supportive Counseling (SWSC) Intervention

Christian Nelson, PhD

Rebecca Saracino, PhD

This study is being done to see if a new psychotherapy intervention called Cancer and Aging: Reflections for Elders (CARE) can effectively treat depression and distress in older cancer patients. CARE is a 5-session intervention that takes place over the phone. This study will compare CARE with the Social Work and Supportive Counseling (SWSC) intervention, which also takes place over the phone. SWSC is a standard psychotherapeutic intervention that has been shown to be a supportive and effective form of treatment for distress for patients with cancer. The researchers will look at which intervention is more effective in treating depression and distress in participants.

This study is designed to test CARE delivered by telephone to improve cancer care for the population of older adults in a larger two-arm Randomized Controlled Trial (RCT).

A New Psychotherapy Intervention for Older Cancer Patients

Cancer and Aging Reflections for Elders (CARE): A Geriatric-Specific Psychotherapy for Older Adults With Cancer

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.

This 14-item scale, which has been well tested in cancer populations including elderly patients with cancer, has depression and anxiety subscales of seven items each. It is considered particularly useful for patients with chronic disease because of the absence of somatic items that often confound the determination of psychiatric problems among the medically ill.

Memorial Sloan Kettering Cancer Center

Nutritional and Metabolic Diseases

All Conditions

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Supervised patient-tailored intensity-modulated physical training

1. Supervised Physical Training in SeniorGym for 12 weeks: 1) Aerobic exercise: Patient-tailored intensity-modulated ergometer training for the limbs; 2) Resistance exercise: Patient-tailored resistance exercise by Theraband for the limbs
2. Nutrition intervention for 24 weeks: Dietitian consultation, education and intervention for 24 weeks

Physical training

Chih Chieh Yen, MD

Yi Hsuan Lin

Jui Hung Tsai, MD

I Ting Liu, MD

Ying Tzu Huang, MD

Shuen Ru Yang, MD

Sheng Fu Liang, Ph.D.

Li Chieh Kuo, Ph.D.

Chih Chun Lin, Ph.D.

The goal of the clinical trial is to evaluate the feasibility and efficacy of physical training for elderly cancer patients at risk of cancer cachexia. The main questions it aims to answer are:

* Whether a physical training program is feasible in elderly cancer patients with cachexia?
* What is the efficacy of a physical training program in reducing the severity of cancer cachexia in elderly cancer patients?

Participants will receive a 12-week supervised patient-tailored intensity-modulated physical training and being assessed for the severity of cancer cachexia before and after the training.

The trial is to investigate the feasibility and efficacy of an artificial intelligence-based patient-tailored intensity-modulated physical training for cancer patients aged over 65 at risk of cancer cachexia. The primary endpoint is simplified cancer CAchexia SCOre (MiniCASCO) reduction. Secondary endpoints include geriatric assessment, physical activity and sarcopenia. This is an open-label, single-arm, single-center phase II investigator-initiated trial. The investigators assume a reduction of MiniCASCO by 10% after trial intervention. Under a statistical power of 80% and a probability of type I error at 0.1 (two-tailed), a minimal of 49 participants will be enrolled. All participants will receive a 12-week supervised physical training and nutritional intervention. Efficacy assessments will be conducted at baseline (week 0), post-intervention (week 12) and follow-up period (week 24). The investigators anticipate that the optimal patient-tailored training program is feasible and improves the symptoms and severity of elderly cancer cachexia. The results may shed light on the debilitating and burdensome condition and provide information on future clinical trials.

Physical Training for Elderly Cancer Patients With Cachexia

Physical Training for Elderly Cancer Patients With Cachexia (TEECH-01): a Prospective Clinical Trial

The study protocol, statistical analysis plan and individual information are to be shared upon reasonable request to the study principal investigator.

Health-related quality of life:

A total of 10 standardized questions from EORTC-QLQ C30 are asked to the participants. The answers are graded as none/not at all, a little/slightly, average/moderately, or a lot/considerably and each question is given 0, 0.25, 0.75 or 1.0 point, respectively. A sum-up score of 0 to 10 will be recorded and of those with a greater score indicate a poorer quality of life.

Nutrition:

A total of six questions on food intake, weight loss, mobility, psychological stress/acute disease, the presence of dementia/depression, and body mass index will be graded. A total score, ranging from 0 to 14, will be recorded and of those with a score ≤ 11 indicate a nutritional deficit.

A simplified version for the scoring of the severity of cancer cachexia:

A total score of 0 to 100 points are recorded and graded as minimal (0 to 14), mild (15 to 28), moderate (29 to 46) or severe cachexia (47 to 100)

Geriatric assessment:

A total of 6 domains (cognitive, mobility, nutrition, visual, hearing and depressive symptoms) are included and be given a score of 1 on each if screened positive (a total score from 0 to 6). Of those who scored greater than 2 will be considered "impaired".

Hand grip strength, Gait speed, Body mass index, Sit-to-stand, Back stretch, Sit reach, Single leg stand, Up-and-go, 2-minute step, 6-minute walk test and Timed up-and-go:

A total of 11 items will be recorded and calculated for the percentage difference, which is equivalent to the {\[absolute change between week 12 (end of training) and week 0 (trial enrollment) testing result\] / week 0 testing result } x 100 %. A mean percentage difference of the 11 items, ranging from 0 to 100%, will be calculated and of those with a greater mean percentage difference indicate a greater post intervention change.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A New Psychotherapy Intervention for Older Cancer Patients	NCT04452825	Cancer	Cancer and Agin... Social Work and...	70 Years -	Memorial Sloan Kettering Cancer Center
Physical Training for Elderly Cancer Patients With Cachexia	NCT05915325	Geriatric Asses... Cancer Cancer Cachexia	Physical traini...	65 Years -	National Cheng-Kung University Hospital
A New Psychotherapy Intervention for Older Cancer Patients	NCT04452825	Cancer	Cancer and Agin... Social Work and...	70 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for geriatric cancer