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Randomized Controlled Trial
. 2023 Aug 21;57(9):765-776.
doi: 10.1093/abm/kaad024.

Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial

Payton Solk  1 , Jing Song  1 , Whitney A Welch  1 , Bonnie Spring  1 , David Cella  1 , Frank Penedo  2 , Ron Ackermann  1 , Kerry S Courneya  3 , Juned Siddique  1 , Hannah Freeman  1 , Julia Starikovsky  1 , Abby Mishory  1 , Jacqueline Alexander  1 , Melanie Wolter  1 , Lillian Carden  1 , Siobhan M Phillips  1
Affiliations
Randomized Controlled Trial

Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial

Payton Solk et al. Ann Behav Med. .

Abstract

Background: Moderate to vigorous physical activity (MVPA) interventions improve patient-reported outcomes (PROs) of physical and psychological health among breast cancer survivors (BCS); however, the effects of specific intervention components on PROs are unknown.

Purpose: To use the Multiphase Optimization Strategy (MOST) to examine overall effects of the Fit2Thrive MVPA promotion intervention on PROs in BCS and explore whether there are intervention component-specific effects on PROs.

Methods: Physically inactive BCS [n = 269; Mage = 52.5 (SD = 9.9)] received a core intervention (Fitbit + Fit2Thrive smartphone app) and were randomly assigned to one of 32 conditions in a full factorial experiment of five components ("on" vs. "off"): (i) support calls, (ii) deluxe app, (iii) text messages, (iv) online gym, and (v) buddy. Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires assessed anxiety, depression, fatigue, physical functioning, sleep disturbance and sleep-related impairment at baseline, post-intervention (12-week), and 24-week follow-up. Main effects for all components at each time point were examined using an intention to treat mixed-effects model.

Results: All PROMIS measures except sleep disturbance significantly improved (p's < .008 for all) from baseline to 12-weeks. Effects were maintained at 24-weeks. The "on" level of each component did not result in significantly greater improvements on any PROMIS measure compared to the "off" level.

Conclusions: Participation in Fit2Thrive was associated with improved PROs in BCS, but improvements did not differ for "on" vs. "off" levels for any component tested. The low-resource Fit2Thrive core intervention is a potential strategy to improve PROs among BCS. Future studies should test the core in an RCT and examine various intervention component effects in BCS with clinically elevated PROs.

Trial registration: ClinicalTrials.gov NCT03131440.

Keywords: Cancer survivorship; Patient-reported outcome measures; Physical activity; mHealth.

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Figures

Fig. 1.
Fig. 1.
Consolidated Standards of Reporting Trials diagram depicting participant flow through study.
See this image and copyright information in PMC

References

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