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SurvivorshipNCT04163042

Physical Activity Counselling for Young Adult Cancer Survivors

A study testing 12-week videoconferencing behavioural support intervention to promote physical activity behaviour in people with Survivorship and Cancer, run by University of Ottawa at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Survival rates for cancer are increasing, resulting in more young adult cancer survivors living with lingering side effects. Physical activity has been shown to improve the quality and length of life in young adult cancer survivors; yet, few are active enough, and little is currently being done to promote physical… Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Survivorship, Cancer
What is being tested?
12-week videoconferencing behavioural support intervention to promote physical activity behaviour
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteCanada
Study dates
1 Mar 2021to 21 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Currently between the ages of 18-39 years;
  • Received a first diagnosis of invasive cancer between the ages of 18-39 years;
  • Completed primary treatment for cancer <5 years;
  • Able to provide informed consent in English or French;
  • Have approval of a healthcare provider to participate in the trial;
  • Have access to videoconferencing technology (e.g., Skype, Google Hangouts, FaceTime).

Who cannot join

  • Have evidence of current cancer (recurrent or secondary cancer or relapse);
  • Currently meeting the Canadian Society for Exercise Physiology aerobic physical activity guidelines for cancer survivors in the month prior to enrolment (i.e., 150 minutes/week of moderate-to-vigorous intensity aerobic physical activity);
  • Are non-ambulatory.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Ottawa

    Ottawa, Ontario, K1N6N5

Other trials in Canada

About this study

Survival rates for cancer are increasing, resulting in more young adult cancer survivors living with lingering side effects. Physical activity has been shown to improve the quality and length of life in young adult cancer survivors; yet, few are active enough, and little is currently being done to promote physical activity in this population. The investigators developed a novel behaviour support intervention to promote physical activity in young adult cancer survivors. In this two-arm pilot randomized controlled trial, the investigators aim to: (1) assess trial and intervention feasibility, (2) assess trial and intervention acceptability, and (3) generate data on physical activity behaviour. Young adult cancer survivors will be randomized to receive either a 12-week behaviour support intervention delivered via videoconferencing or will be allocated to usual care.

Read the detailed description

Background: Young adults commonly experience persistent side effects following cancer treatment that impair quality of life. Physical activity (PA) holds promise as an intervention to mitigate persistent side effects and improve quality of life. Yet, few young adults are active enough to incur these benefits and efforts to promote PA following cancer treatment are lacking. Therefore, the investigators developed a novel behaviour support intervention to promote PA in young adults following cancer treatment, and have undertaken a pilot randomized controlled trial (RCT) to determine whether the intervention delivered via videoconferencing is both feasible and acceptable. Specifically, the aims of this ongoing parallel group two-arm pilot RCT are to: (1) assess trial and intervention feasibility and acceptability, and (2) generate data on PA behaviour.

Methods: Young adults who have completed cancer treatment are recruited from across Canada. Recruits are randomized to the intervention group (IG; i.e., a 12-week behaviour support intervention delivered via videoconferencing) or usual care (UC; no intervention). Drawing on the CONSORT 2010 statement and flow diagram, several feasibility outcomes pertaining to enrolment, allocation, follow-up, and analysis are tracked by study staff. Acceptability is assessed through interviews exploring IG and UC participants' experiences, thoughts, and perspectives of the trial, IG participants' views of the intervention and its mode of delivery, and PA counsellors' experiences delivering the intervention. PA is measured using accelerometers. Assessments take place at baseline (pre-randomization), post-intervention period, and at follow-up (24 weeks post-baseline).

Discussion: Feasibility and acceptability data will help determine if/what changes/modifications are needed to improve the trial protocol and/or intervention, and will inform the timeline for a definitive RCT. The PA behaviour data collected will inform sample size calculation for a future RCT that aims to test the effects of this intervention in young adults following cancer treatment.

Conditions
Survivorship, Cancer
Being tested
12-week videoconferencing behavioural support intervention to promote physical activity behaviour
Keywords
Physical activity, Behavioural support, Oncology, Telehealth, Self-determination theory, Behaviour change techniques, Young adult cancer survivors
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 12-week videoconferencing behavioural support intervention to promote physical activity behaviourBehavioural

    Participants in Group A will receive six real-time, 1-on-1 60-minute sessions led by a physical activity counsellor over a 12-week period. Sessions will be delivered via videoconferencing and will aim to provide young adult cancer survivors with support as well as the knowledge, skills, and confidence to identify and overcome challenges to engaging in physical activity in order to increase physical activity behaviour and enhance patient-reported outcomes.

Study groups in NCT04163042
Study groupRoleWhat they receive
Group A: Videoconferencing interventionExperimentalParticipants allocated to group A will receive a behavioural support intervention via real-time videoconferencing.
Receives: Behavioral: 12-week videoconferencing behavioural support intervention to promote physical activity behaviour
Group B: Usual careNo interventionParticipants allocated to group B will receive usual care and will be advised to continue with their regular activities of daily living.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rates

    The number of eligible participants who enrol in the trial out of the number who are referred

    Measured: Duration of study (24 months)

  2. Adherence rates

    The number of intervention sessions attended out of the total recommended as part of the intervention

    Measured: Duration of study (24 months)

  3. Acceptability of the trial and intervention

    Participants will be asked to share their experiences, thoughts, and perspectives of the trial, the physical activity counsellor and the intervention by responding to open and close-ended questions during a semi-structured interview. Responses to close-ended questions will range from 1 ('poor' or 'not satisfied at all') to 10 ('excellent' or 'extremely satisfied').

    Measured: At week 12

  4. Retention rates

    The number of participants completing all three scheduled assessments.

    Measured: Duration of study (24 months)

  5. Data completeness: Quantitative measures

    The percentage of missing data on quantitative measures.

    Measured: Duration of study (24 months)

  6. Data completeness: Qualitative interviews

    The number of participants completing the acceptability interview following the intervention.

    Measured: Duration of study (24 months)

Secondary outcomes (9)
  1. Physical activity behaviour: 7-day accelerometer wear (objective physical activity behaviour)

    Change in participants' objective levels of physical activity as measured by accelerometers (ActiGraph GT3X+), which will be worn for a 7-day period across baseline (week 0), post-intervention (week 12), and follow-up (week 24).

    Measured: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

  2. Health-related quality of life: RAND 36-Item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)

    Change in participants' self-reported health-related quality of life across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). The SF-36 measures eight dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 scale, with higher scores representing a more favourable health state.

    Measured: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

  3. Positive and negative affect: Positive and Negative Affect Schedule (PANAS-SF; Watson, Clark & Tellegen, 1998)

    Change in participants' self-reported positive and negative affect across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a scale from 1 ('Very slightly or not at all') to 5 ('Extremely'). Items in the positive scale are averaged together to create a Positive Affect Score, and items in the negative scale are averaged together to create a Negative Affect Score. Higher positive and negative scores represent higher positive and negative affect, respectively.

    Measured: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

  4. Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9; Kroenke, Spitzer & Williams, 2001)

    Change in participants self-reported depressive symptoms across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a 0 ('Not at all') to 3 ('Nearly every day') scale with higher scores representing greater severity of depressive symptoms.

    Measured: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

  5. Anxiety symptoms: 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7; Kroenke, Spitzer & Williams, 2006)

    Change in participants self-reported anxiety symptoms across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a 0 ('Not at all') to 3 ('Nearly every day') scale, with higher scores representing greater severity of anxiety symptoms.

    Measured: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

  6. Impact of cancer: Impact of Cancer Instrument - Adolescent and Young Adult Module (Husson & Zebrack, 2017)

    Change in participants' self-reported perceptions of cancer impact from baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). Each item is scored on a scale from 0 ('Strongly disagree') to 4 ('Strongly agree'), with higher scores representing greater impact of cancer.

    Measured: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

  7. Motivation for physical activity: Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3; Markland & Tobin, 2004)

    Change in participants' self-reported motivation for physical activity across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). This measure taps six behavioural regulations in the physical activity context: amotivation, external, introjected, identified, integrated, and intrinsic motivation. Each item is scored on a scale from 0 ('Not true for me') to 4 ('Very true for me'), with higher scores reflecting greater amotivation, external, introjected, identified, integrated, and intrinsic motivation for physical activity.

    Measured: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

  8. Basic psychological need satisfaction in relation to physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers & Rodgers, 2006)

    Change in participants self-reported psychological need satisfaction in relation to physical activity across baseline (week 0), post-intervention (week 12) and post-intervention follow-up (week 24). The PNSE measures perceptions of competence, autonomy and relatedness in relation to physical activity. Each item is scored on a scale from 1 ('False') to 6 ('True'), with higher scores representing greater perceived competence, autonomy and relatedness.

    Measured: Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

  9. Autonomy support, structure and interpersonal involvement: Health Care Climate Questionnaire (Marcus et al., 1992)

    Participants perceived sense of autonomy support, structure and interpersonal involvement for physical activity post-intervention (week 12). Each item is scored on a scale from 1 ('Strongly disagree') to 7 ('Strongly agree'), with higher scores representing greater perceived autonomy support, structure and interpersonal involvement for physical activity.

    Measured: Post-intervention (week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2019
  2. Study start1 Mar 2021
  3. Primary completion30 Sep 2022
  4. Study completion21 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04163042
Sponsor's protocol ID
20190643-01H
Status last verified
Jan 2024
First submitted
5 Nov 2019
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PubMed 1593914
  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PubMed 3397865
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171
  • Husson O, Zebrack BJ. Psychometric Evaluation of an Adolescent and Young Adult Module of the Impact of Cancer Instrument. J Adolesc Young Adult Oncol. 2017 Mar;6(1):159-170. doi: 10.1089/jayao.2016.0038. Epub 2016 Sep 21.

    PubMed 27654343
  • Marcus BH, Rakowski W, Rossi JS. Assessing motivational readiness and decision making for exercise. Health Psychol. 1992;11(4):257-61. doi: 10.1037//0278-6133.11.4.257.

    PubMed 1396494
  • Brunet J, Price J, Gillison F, Standage M, Taljaard M, Beauchamp MR, Reed J, Srikanthan A. Feasibility and acceptability of a parallel, two-arm randomized controlled trial to evaluate an online physical activity behavior counseling intervention for young adults diagnosed with cancer: a mixed-methods pilot study. Pilot Feasibility Stud. 2025 Nov 4;11(1):131. doi: 10.1186/s40814-025-01701-w.

    PubMed 41189005
  • Brunet J, Price J, Srikanthan A, Gillison F, Standage M, Taljaard M, Beauchamp MR, Reed J, Wurz A. The physicAl aCtivity Counselling for young adult cancEr SurvivorS (ACCESS) trial: A protocol for a parallel, two-arm pilot randomized controlled trial. PLoS One. 2022 Dec 30;17(12):e0273045. doi: 10.1371/journal.pone.0273045. eCollection 2022.

    PubMed 36584027

Questions about this trial

What is this clinical trial studying?

A study testing 12-week videoconferencing behavioural support intervention to promote physical activity behaviour in people with Survivorship and Cancer, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rates (time frame: Duration of study (24 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04163042, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

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