A pilot randomised controlled trial of a structured exercise intervention after the completion of cancer treatment in adolescents and young adults

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000527561
• Date of registration: 26/05/2015
• Prospective Registration: No
• Primary sponsor: Australian and New Zealand Children's Haematology and Oncology Group
• Public title: A pilot randomised controlled trial of a structured exercise intervention after the completion of cancer treatment in adolescents and young adults
• Scientific title: A pilot randomised controlled trial of a structured exercise intervention after the completion of cancer treatment in adolescents and young adults
• Date of first enrolment: 13/04/2015
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000527561.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Mr Morgan Atkinson

• Name: Mr Morgan Atkinson

Key inclusion & exclusion criteria

Inclusion criteria: - Participants must be aged between 15 and 25 years of age
- Diagnosed with a haematological malignancy or solid tumour
- Completed systemic cancer treatment e.g. chemotherapy, radiation therapy or a combination of both (participants who have undergone surgery will only be eligible for the trial if surgery is used in combination with chemotherapy or radiation).
- Cancer therapy completed within the previous two months (or have started maintenance therapy for acute lymphoblastic leukaemia (or lymphoblastic lymphoma) within the past two months)
- Medically stable (as determined by a medical practitioner) and written clearance from a doctor in their treating team to undertake a progressive exercise program.
Exclusion criteria: - Cognitive impairment (determined by a medical practitioner)
- Patients who undergo surgery only
- <6 months life expectancy
- Absolute contraindications to exercise e.g. unstable angina, uncontrolled heart failure, acute systemic infection accompanied by fever.
- Insufficient English to participate in the exercise programme and exercise assessments, or to complete the questionnaires


Age minimum: 15 Years
Age maximum: 25 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Any cancer

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Cancer;
Cancer

Intervention(s)

Subjects randomised to the intervention arm will receive a 10-week intensive exercise programme from an exercise physiologist. Specifically, they will be asked to attend two supervised gym or home-based exercise sessions per week for 10 weeks. An Exercise Physiologist will design an individual exercise prescription for each participant based on results from the baseline functional assessments. Exercise will be mixed mode and will incorporate a combination of aerobic and resistance exercises. Exercises to improve flexibility will be included at the end of each exercise session. Exercise sessions will last no longer than 60 minutes. Over time it is expected that each participant will engage in 30 minutes of aerobic exercise and 30 minutes of resistance training, plus flexibility exercises. Exercise intensity will be monitored using heart rate monitors and participants will be encouraged to exercise at a moderate to high intensity (60% to 85% heart rate max). The Exercise Physiologist will aim to progress exercise intensity as tolerated. Participants will also be encouraged to engage in aerobic exercise outside of supervised exercise sessions.
Participants will also be provided with informal education sessions on the importance of exercise post cancer therapy. Parents and/or partners of participants will also be invited and encouraged to attend education sessions regarding the importance of physical activity and exercise post treatment.

Primary Outcome(s)

Quality of Life (as measured by AQoL-6D, EORTC-C30, FACT-G, Peds-QL (AYA modification)[10 weeks after commencement of the exercise intervention]

Fatigue score (as measured by FACIT fatigue scale)[10 weeks after commencement of the exercise intervention]

Functional capacity (as measured by Cardiopulmonary exercise testing / VO2 max and other standardised measures of fitness) [10 weeks after commencement of the exercise intervention]

Secondary Outcome(s)

Functional capacity (as measured by Cardiopulmonary exercise testing / VO2 max and other standardised measures of fitness) [6 months after commencement of the exercise intervention]

Fatigue Score (as measured by FACIT-fatigue scale)[6 months after commencement of the exercise intervention]

Quality of Life (as measured by AQoL-6D, EORTC-C30, FACT-G, Peds-QL (AYA modification)[6 months after commencement of the exercise intervention]

Participation in physical fitness activities (as measured by Godin Leisure Time Exercise questionnaire)[6 months after commencement of the exercise intervention]

Secondary ID(s)

Nil

Source(s) of Monetary Support

CanTeen Australia

Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)

Ethics review

Status: Approved
Approval date:
Contact:

Women's and Children's Health Network Human Research Ethics Committee