Exercise Intervention to Improve Quality of Life in Patients With Colorectal Cancer

NCT05224518 | Recruiting

• 1 other identifier: 110-146-E
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to explore the 12-week effectiveness of home exercise intervention for colorectal cancer patients in improving fatigue, sleep, muscle endurance, and quality of life. A. Explore the effect of "12-week home exercise intervention" in improving the fatigue of colorectal cancer patients. B. Explore the effect of "12-week home exercise intervention" in improving the sleep quality of patients with colorectal cancer. C. Explore the effect of "12-week home exercise intervention" in improving the muscle endurance of patients with colorectal cancer. D. Explore the effect of "12-week home exercise intervention" in improving the quality of life of colorectal cancer patients.

Conditions

Colorectal Cancer; Fatigue; Quality of Life

Keywords

elastic band training; colorectal cancer; exercises

Outcome Measures

Primary Outcomes (14)

• Quality of life of cancer patients(EORTC QLQ-C30)

  This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).

  baseline

• Quality of life of cancer patients(EORTC QLQ-C30)

  This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).

  1rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-C30)

  This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).

  2rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-C30)

  This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).

  3rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-C30)

  This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).

  6rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-C30)

  This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).

  12rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-C30)

  This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).

  24rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-CR29)

  The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom.

  baseline

• Quality of life of cancer patients(EORTC QLQ-CR29)

  The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom.

  1rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-CR29)

  The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom.

  2rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-CR29)

  The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom.

  3rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-CR29)

  The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom.

  6rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-CR29)

  The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom.

  12rd month after recruited

• Quality of life of cancer patients(EORTC QLQ-CR29)

  The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom.

  24rd month after recruited

Secondary Outcomes (25)

• Brief Fatigue Inventory-Taiwanese (BFI-T)

  baseline

• Brief Fatigue Inventory-Taiwanese (BFI-T)

  1rd month after recruited

• Brief Fatigue Inventory-Taiwanese (BFI-T)

  2rd month after recruited

• Brief Fatigue Inventory-Taiwanese (BFI-T)

  3rd month after recruited

• Brief Fatigue Inventory-Taiwanese (BFI-T)

  6rd month after recruited

Study Arms (2)

home-based elastic band training group

EXPERIMENTAL

The interventional group received 12 weeks of home-based elastic band training, three days a week, with progressive, medium-intensity exercise.

Behavioral: elastic band training

stretching exercises group

ACTIVE COMPARATOR

The control group received home stretching exercises three days a week for 12 weeks.

Behavioral: elastic band training

Interventions

elastic band training BEHAVIORAL

elastic band training include stretching exercises

Also known as: stretching exercises

home-based elastic band training group; stretching exercises group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above the age of 20, with colorectal cancer pathological stage in situ, I, II, and III.
• Coherent, with no mental abnormalities.
• Able to read Mandarin or communicate in Mandarin and Taiwanese to complete the questionnaire.
• Provided informed consent.
• No physical disabilities.

You may not qualify if:

• Acute inflammation of the limbs and joints.
• Previous abdominal surgery within 3 months.
• Symptomatic cardiovascular events.
• Long-term anti-depressant drug use.
• Unilateral restrictions of the upper or lower limbs.
• History of medium- or high-intensity exercise for more than half a year.
• Having colostoma or ileostoma.

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead
• National Taipei University of Nursing and Health Sciences: collaborator

Study Sites (1)

NTU Hsin-Chu Hospital

Hsinchu, 300, Taiwan

RECRUITING

Related Publications (6)

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 BACKGROUND

• Chen Y, Niu M, Zhang X, Qian H, Xie A, Wang X. Effects of home-based lower limb resistance training on muscle strength and functional status in stable Chronic obstructive pulmonary disease patients. J Clin Nurs. 2018 Mar;27(5-6):e1022-e1037. doi: 10.1111/jocn.14131. Epub 2018 Feb 6.

  PMID: 29076609 BACKGROUND

• Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.

  PMID: 23851406 BACKGROUND

• Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

  PMID: 31626055 RESULT

• Patel AV, Friedenreich CM, Moore SC, Hayes SC, Silver JK, Campbell KL, Winters-Stone K, Gerber LH, George SM, Fulton JE, Denlinger C, Morris GS, Hue T, Schmitz KH, Matthews CE. American College of Sports Medicine Roundtable Report on Physical Activity, Sedentary Behavior, and Cancer Prevention and Control. Med Sci Sports Exerc. 2019 Nov;51(11):2391-2402. doi: 10.1249/MSS.0000000000002117.

  PMID: 31626056 RESULT

• Uster A, Ruehlin M, Mey S, Gisi D, Knols R, Imoberdorf R, Pless M, Ballmer PE. Effects of nutrition and physical exercise intervention in palliative cancer patients: A randomized controlled trial. Clin Nutr. 2018 Aug;37(4):1202-1209. doi: 10.1016/j.clnu.2017.05.027. Epub 2017 Jun 8.

  PMID: 28651827 RESULT

Related Links

• National cancer institute.

MeSH Terms

Conditions

Colorectal Neoplasms; Fatigue; Motor Activity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hui-Mei Chen

  University of Nursing and Health Sciences, Taipei, Taiwan

  STUDY CHAIR

Central Study Contacts

Zih-Yun Deng, BSN

CONTACT

0917741835; debby820130@gmail.com

Hui-Mei Chen, PhD

CONTACT

02-28227101; alice@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: February 4, 2022
• Study Start: February 21, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 24 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal and receive the authors consent.

Locations

TW (1)