Tailored Exercise Interventions to Reduce Fatigue in Cancer Survivors

NCT03049384 | Completed

• 1 other identifier: HREBA.CC-16-1010
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that can persist for months or years in cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. However, exercise interventions have not been tailored to alleviate CRF in fatigued cancer survivors, and thus the potential to alleviate CRF may not have been realized. The primary aim of this research is to investigate the effect of a traditional vs. tailored 12-week exercise intervention on self-reported CRF severity.

Conditions

Cancer-related Fatigue

Outcome Measures

Primary Outcomes (1)

• Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale

  Self-report questionnaire for the assessment of cancer-related fatigue.

  Baseline to after the 12-week intervention, at 6 month and 12 month follow up.

Secondary Outcomes (43)

• Assessment of change in The Functional Assessment of Cancer Therapy - General (FACT-G)

  Baseline and after the 12-week intervention.

• Assessment of change in Edmonton Symptom Assessment System-revised tiredness scale

  Baseline and after the 12-week intervention, and during follow up (6 and 12 months).

• Maximal Isometric Force in the Knee Extensors

  Baseline and after the 12-week intervention.

• Cortical Voluntary Activation

  Baseline and after the 12-week intervention.

• Voluntary Activation

  Baseline and after the 12-week intervention.

Study Arms (2)

Traditional Exercise

ACTIVE COMPARATOR

A classical exercise intervention based on current guidelines for cancer survivors.

Other: Traditional Exercise

Tailored Exercise

EXPERIMENTAL

A tailored and individualized exercise intervention based on the results of pre-intervention testing.

Other: Tailored Exercise

Interventions

Traditional Exercise OTHER

The traditional exercise group will undertake a supervised exercise intervention involving aerobic exercise and light resistance training, in line with published guidelines for exercise in cancer survivors.

Traditional Exercise

Tailored Exercise OTHER

The tailored training group will be prescribed an individualized exercise intervention designed specifically to counteract deficits (e.g. neuromuscular) of difficulties (e.g. sleep disturbance) identified during pre-intervention testing.

Tailored Exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years;
• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score ≤ 34;
• Completion of treatment in ≥ 3 months and ≤ 5 years preceding enrollment;
• Approval received from personal physician and/or a Canadian Society for Exercise Physiology-Clinical Exercise Physiologist (CSEP-CEP);
• Command of the English language.

You may not qualify if:

• Contraindication to experimental procedures including transcranial magnetic stimulation (TMS);
• Diagnosed as having obstructive sleep apnea or anemia;
• Currently participating in a structured exercise intervention;
• Participant is pregnant.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

• Twomey R, Martin T, Temesi J, Culos-Reed SN, Millet GY. Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial. BMC Cancer. 2018 Jul 24;18(1):757. doi: 10.1186/s12885-018-4668-z.

  PMID: 30041626 DERIVED

Study Officials

• Guillaume Millet, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 10, 2017
• Study Start: March 9, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)