Clinical trial NCT03691545: Making Healthy Choices: Does Having an Online Health Coach Help?
Official title: Helping Rural-living Young Adult Cancer Survivors Make Healthy Lifestyle Choices: Does Having a Telehealth Personal Health Coach Help?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Dietary Modification
Keywords: physical activity
fruit and vegetable consumption
telehealth
young adult cancer survivors
rural-dwelling
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participating in regular physical activity and consuming a diet high in fruits and vegetables can aid in the management of various acute and chronic side effects of cancer treatment; however, few rural-dwelling young adult cancer survivors are active enough and consume enough fruits and vegetables to accrue benefits. Telehealth interventions show promise for helping these young adults increase their motivation to participate in these behaviours by addressing barriers associated with accessing face-to-face behaviour counselling services (e.g., time commitment, travel distance). Yet, few researchers have examined the feasibility and acceptability of a telehealth intervention that provides motivational support grounded in self-determination theory for these health behaviours in rural-dwelling young adult cancer survivors. Based on previous research, the researchers reasoned that rural-dwelling young adult cancer survivors' physical activity and fruit and vegetable consumption would be more likely to increase if they participated in a telehealth intervention therefore, the researchers aim to test the feasibility, acceptability, and preliminary efficacy of the intervention. The researchers also aim to assess if changes in perceived basic psychological need satisfaction, behaviour regulation, and perceived autonomy support are associated with changes in physical activity and fruit and vegetable consumption.


Eligibility criteria: Inclusion Criteria:

* Are between the ages of 20-39 years
* Live in a rural area (i.e., areas with \<35,000 inhabitants)
* Have completed primary treatment for non-metastatic cancer
* Are not currently meeting the American Cancer Society guidelines for physical activity and fruit and vegetable consumption
* Have access to the Internet and to audio-visual devices
* Are willing to provide informed consent to participate in this study and willing to follow study protocol
* Able to read and understand English
* Are ambulatory

Exclusion Criteria:

* Have a serious condition that precludes safe participation in physical activity
* Have symptomatic heart or vascular diseases (angina, peripheral vascular disease, congestive heart failure)
* Have severe hypertension
* Have had a recent stroke
* Have a chronic obstructive pulmonary disease
* Have severe insulin-dependent diabetes mellitus
* Have renal disease
* Have liver disease

Primary outcomes:
measure: Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000).
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Fruit and vegetable intake behaviour: Behavioural Risk Factor Surveillance System Fruit and Vegetable section (BRFSS-FV; Trowbridge, Wong, Byers, & Serdula, 1990)
timeFrame: Baseline (week 0) and post-intervention (week 12)
Secondary outcomes:
measure: Basic psychological needs satisfaction for physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Basic psychological need satisfaction for fruit and vegetable consumption: Psychological Need Satisfaction questionnaire (PNS; Deci, Ryan, Gagne, Leone, Usunov, & Kornazheva, 2001)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Motivational regulations for physical activity: Exercise Treatment Self-Regulation Questionnaire (TSRQ-E; Williams, Deci, & Ryan, 1998)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Motivational regulations for fruit and vegetable consumption: Dietary Self-Regulation questionnaire (DSR; Williams, Deci, & Ryan, 1998)
timeFrame: Baseline (week 0) and post-intervention (week 12)
measure: Perceived autonomy support: Health Care Climate Questionnaire (HCCQ; Williams, Grow, Freedman, Ryan, & Deci, 1996)
timeFrame: Post-intervention (week 12)
measure: Recruitment rates
timeFrame: Duration of recruitment and intervention phase (12 weeks)
measure: Retention rates for intervention
timeFrame: Duration of recruitment and intervention phase (12 weeks)
measure: Adherence rates for intervention
timeFrame: Duration of recruitment and intervention phase (12 weeks)
measure: Acceptability of intervention: Semi-structured interviews
timeFrame: Post-intervention (12 weeks)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
References:
citation: Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
citation: Deci, E. L., Ryan, R.M., Gagne, M., Leone, D.R., Usunov, J., & Kornazheva, B.P. (2001). Need satisfaction, motivation, and well-being in the work organizations of a former eastern bloc country: A cross-sectional study of self-determination. Journal of Personality and Social Psychology, 27(8), 930-942.
citation: Trowbridge FL, Wong FL, Byers TE, Serdula MK. Methodological issues in nutrition surveillance: the CDC experience. J Nutr. 1990 Nov;120 Suppl 11:1512-8. doi: 10.1093/jn/120.suppl_11.1512.
citation: Williams, G. C., Deci, E. L., & Ryan, R. M. (1998). Building health-care partnerships by supporting autonomy: Promoting maintained behavior change and positive health outcomes. In A. L. Suchman, P. Hinton-Walker, & R. Botelho (Ed.), Partnerships in healthcare: Transforming relational process (pp. 67-87). Rochester, NY: University of Rochester Press.
citation: Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.
citation: Wilson, P. M., Rogers, W. T., Rodgers, W. M., & Wild, T. C. (2006). Psychological need satisfaction in exercise scale. Journal of Sport & Exercise Psychology, 28, 231-251.
citation: Price J, Brunet J. Feasibility and acceptability of a telehealth behavior change intervention for promoting physical activity and fruit and vegetable consumption among rural-living young adult cancer survivors. J Psychosoc Oncol. 2021;39(6):715-733. doi: 10.1080/07347332.2021.1896616. Epub 2021 Apr 2.