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Completed

NCT Number: NCT05376293

Be-Active Study - Increasing Physical Activity in Cancer Survivors

Rates of cancer survivorship are on the rise and cancer survivors face unique health challenges that are common across cancer types that last well beyond the cessation of cancer treatment (e.g., increased fatigue, anxiety/depression, fear of recurrence, risk of cardiovascular disease, and lower health-related quality of life). While physical activity (PA) has favorable effects on these health parameters and is highly recommended for cancer survivors, this population engages in lower-than-average levels of PA. Effective PA interventions with high translation potential are important for improving the health of this population. The Internet overcome barriers to traditional face-to-face treatment programs (e.g., high cost, participant burden, geographical constraints) and represents a disseminable intervention approach. While behaviorally-based Internet programs significantly increase PA in other health domains, the application of these programs to cancer survivors is relatively new. This study will randomize 50 cancer survivors to a 12-week Internet PA program or usual-care newsletter condition. Primary outcomes include intervention engagement and program satisfaction related to the Internet program and changes in PA by intervention arm at post-treatment (3 months). Secondary aims include comparison of intervention arms on changes in sleep, weight, fatigue, anxiety/depression, health-related quality of life, and fear of recurrence.

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Key information

Conditions

Physical Activity Behavior Cancer Survivors Exercise Motor Activity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed cancer diagnosis and have either completed all cancer-directed treatment in the past 3-12 months or be on a maintenance/continuous treatment regimen for which they have been stable for at least 3 months
  • Inactive - defined as engaging in <60 min/week of moderate-intensity PA over the past 3 months
  • BMI between 18.5 and 45 kg/m2
  • English speaking
  • Daily Internet access

Exclusion criteria

  • Any medical condition for which physical activity is contraindicated
  • Unable to attend assessment visits in Providence RI

Treatment and study plan

Behavioral Internet program

Behavioral

The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants will be asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.

Informational newsletter condition

Behavioral

Newsletters will focus on the health benefits of regular physical activity, exercise safety, and will provide information on national exercise guidelines.

Primary outcomes

  1. Change in Physical Activity

    Time frame: baseline to 3 months

    Change in minutes/week of moderate-to-vigorous intensity physical activity from baseline to 3 months as assessed by Actigraph accelerometers. Positive number indicates an increase in physical activity

  2. Intervention Engagement - Planning of Physical Activity (Internet Program Only)

    Time frame: weekly from weeks 2-12

    Participants were asked to submit an exercise plan (i.e., when they intended to exercise that week) at the beginning of weeks 2-12. This is the percentage of weeks that an exercise plan was submitted on the study website by the participant.

  3. Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)

    Time frame: weekly during weeks 1-12

    Participants were asked to log their exercise minutes each week on the study website. This is the percentage of weeks that exercise minutes were reported on the study website by the participant over the 12-week period.

  4. Program Satisfaction Via Likert Scale

    Time frame: 3 months

    Participants used a 1-7 Likert scale to answer 'how satisfied are you with the program received?" (higher score indicates greater satisfaction)

Secondary outcomes

  1. Fatigue Measured Via the Brief Fatigue Inventory (BFI)

    Time frame: baseline to 3 months

    The Brief Fatigue Inventory (BFI) assesses the severity of fatigue and the impact of fatigue on daily functioning. An overall fatigue score was calculated as the average of all answered items (range: 0-10) , with higher scores indicating more severe fatigue. Change in BFI score from baseline to 3 months was then calculated (a negative change scores indicates a reduction in fatigue).

  2. Health-related Quality of Life (General Health Subscale) Measured Via the SF-36

    Time frame: baseline to 3 months

    The 'General Health' subscale of the Short Form Health Survey (SF-36) evaluates a person's overall perception of their health. Scores range from 0 to 100, with higher scores indicating better perceived general health. Change scores from baseline to 3 months were then calculated (positive change scores indicate improved general health).

  3. Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)

    Time frame: baseline to 3 months

    Psychological distress was assessed using the 'Global Severity Index' of the Brief Symptom Inventory-18 (BFI-18). Scores range from 0 to 72, with greater scores indicating greater psychological distress. Change in psychological distress from baseline to 3 months was then calculated, with positive change scores indicating increased severity of symptoms such as somatization, depression, and anxiety.

  4. Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)

    Time frame: baseline to 3 months

    A total score from the Fear of Recurrence Inventory - Short Form was used to assess the intensity of fear related to the possibility of cancer returning. Scores range from 0 to 36, with higher scores reflecting a greater severity of fear of cancer recurrence. Change scores from baseline to 3 months were then calculated (negative change scores indicates reduced fear of cancer recurrence)

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • Brown University

Registry information

Official study title

Web-based Intervention for Increasing Physical Activity in Cancer Survivors

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 17, 2022
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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