Behavioral Reinforcement Intervention for Greater Health Trajectories After Childhood Cancer (BRIGHT)

NCT07384286 | Not Yet Recruiting

• 1 other identifier: 286561
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Survivors of childhood cancer have a substantially increased risk of long-term health problems in adulthood, including cardiovascular disease, metabolic disorders, psychological morbidity, and impaired health-related quality of life (HRQoL). These risks are partly related to cancer treatment exposures but are also strongly influenced by modifiable lifestyle factors such as physical activity, diet, body weight, and cardiometabolic risk factors. Although healthy lifestyle behaviors are known to reduce morbidity and mortality in this population, many adult childhood cancer survivors do not meet current lifestyle recommendations and rarely receive structured, tailored support to change health behaviors. The Behavioral Reinforcement Intervention for Greater Health Trajectories (BRIGHT) study aims to evaluate whether a person-centered, remotely delivered lifestyle intervention can improve health-related quality of life and key health markers in adult survivors of childhood cancer with an unhealthy lifestyle. The intervention focuses on increasing physical activity and improving dietary habits through structured video-based coaching delivered by trained health promoters over a 26-week period. BRIGHT is conducted within NOPHO-CARE Sweden, a national population-based cohort of childhood cancer survivors, and uses a register-based randomized controlled design with two randomization steps. First, eligible participants are randomized to be offered the intervention or not, enabling evaluation of the population-level effect of offering the intervention through long-term register-based follow-up. Second, participants who consent to active participation are randomized to immediate or delayed start of the intervention, allowing controlled assessment of short-term intervention effects. The primary research question is whether the BRIGHT lifestyle intervention leads to a clinically meaningful improvement in health-related quality of life, measured by the PROPr utility index derived from PROMIS-29, compared with a control period. Secondary questions address whether the intervention improves physical activity, cardiorespiratory fitness, muscle strength, diet quality, body weight, blood pressure, and cardiometabolic and biological markers, including epigenetic age acceleration. The study also examines feasibility, adherence, and scalability of delivering a person-centered lifestyle intervention within a national survivorship follow-up structure. In addition, BRIGHT investigates whether offering the intervention to the full eligible population leads to long-term reductions in cardiovascular disease, metabolic disease, psychiatric morbidity, and mortality, using national health registers. By combining individual-level efficacy and population-level effectiveness within a single study framework, BRIGHT aims to generate robust evidence to inform future preventive care and long-term follow-up strategies for adult survivors of childhood cancer.

Conditions

Survivors of Childhood Cancer

Keywords

Lifestyle; Survivors of childhood cancer

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

  The primary outcome will be change in HRQoL using the PROPr utility index, derived from patient-reported outcome measures information system (PROMIS)-29.

  from Baseline until 6 months

Secondary Outcomes (15)

• Physical activity

  From baseline until six months for comparison between groups and until 18 months for trajectories.

• Cardiorespiratory fitness

  From baseline until six months for comparison between groups and until 18 months for trajectories.

• Handgrip strength

  From baseline until six months for comparison between groups and until 18 months for trajectories.

• Lower limb strength

  Change from baseline until six months for comparison between groups and until 18 months for trajectories.

• Diet

  Change from baseline until six months for comparison between groups and until 18 months for trajectories.

Study Arms (3)

Register-based follow-up

NO INTERVENTION

Participants in NOPHO-CARE Sweden who are randomized to not being contacted regarding BRIGHT but will only undergo register-based follow-up within NOPHO-CARE Sweden

Waitlist control with cross-over

ACTIVE COMPARATOR

Active participation in BRIGHT. Randomized to waitlist control and start of intervention after 6 months.

Behavioral: Lifestyle Management

Immediate intervention

EXPERIMENTAL

Active participation in BRIGHT and randomized to immediate start of the intervention.

Behavioral: Lifestyle Management

Interventions

Lifestyle Management BEHAVIORAL

Person-centered lifestyle support

Immediate intervention; Waitlist control with cross-over

Eligibility Criteria

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

You may qualify if:

• Participant in NOPHO-CARE Sweden
• Performing \<150 min moderate-vigorous physical activity per week and/or body mass index 28-35.

You may not qualify if:

• Pre-existing diagnosis of heart failure or coronary artery disease
• Uncontrolled hypertension, defined as \>180/100 mmHg
• Other medical reasons that the intervention or outcome assessments are considered unsafe (as decided by a study physician)
• Inability to perform the intervention or outcome assessments due to lack of mobile device (computer, tablet or telephone) with internet access or language barriers.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Centrum för livsstilsintervention

Gothenburg, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Parallel group randomized controlled trial with waitlist design and crossover of control group, plus a parallel group randomized controlled trial for effectiveness.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 3, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

SE (1)