Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors

Physical Activity Clinical Trial

Official title:

Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131440
• Other study ID #: K07CA196840
• Secondary ID: K07CA196840R21CA
• Status: Completed
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: June 17, 2019

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed with Stage I-III breast cancer within the last 5 years

2. Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment

3. English speaking

4. Currently participate in less than 60 minutes of moderate and vigorous physical activity per week

5. Own a smartphone

6. Have access to a computer with Internet

7. Participants may be using adjuvant endocrine therapies.

8. Willing to be waitlisted for future wave if current wave reaches capacity Exclusion Criteria:

-Women will be excluded if they report any of the following:

1. Respiratory, joint or cardiovascular problems precluding physical activity

2. Metastatic disease

3. Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).

ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:

1. A prior cardiovascular event (i.e. stroke, myocardial infarction)

2. Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Physical Activity

Intervention

Behavioral:
• Core
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
• Support Calls
Participants will receive 6 bi-weekly phone calls from study staff.
• App+
Participants will receive "deluxe" version of smartphone app with additional features.
• Online gym
Participants will receive access to online exercise videos.
• App notifications
Participants will receive motivational app notifications
• Buddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to a 12 Week Technology Supported Physical Activity Intervention	Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.	12 weeks
Primary	Participant Retention	Percentage of participants retained at the end of the 12 week intervention of those randomized [(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized*100].	12 weeks
Primary	Intervention Reach	Percentage of individuals randomized of those who were sent a study screening survey	Baseline
Secondary	Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention	Physical activity will be measured at baseline and at 12 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (=2020).	Change from baseline to 12 weeks
Secondary	Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up	Physical activity will be measured at baseline and at 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (=2020).	Change from baseline to 24 weeks
Secondary	Change in Fatigue From Before to After a 12-Week Intervention	Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.	Change from baseline to 12 weeks
Secondary	Change in Fatigue From Pre-Intervention to 24-Week Follow-up	Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.	Change from baseline to 24 weeks
Secondary	Change in Physical Function From Before to After a 12-Week Intervention	Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.	Change from baseline to 12 weeks
Secondary	Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up	Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off.	Change from baseline to 24 weeks
Secondary	Change in Depression From Before to After a 12-Week Intervention	Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.	Change from baseline to 12 weeks
Secondary	Change in Depression From Pre-Intervention to 24-week Follow-up	Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.	Change from baseline to 24 weeks
Secondary	Adherence to During the Full 24-Week Study Period	Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24.	24 weeks
Secondary	Participant Retention at 24 Week Follow-up	Percentage of participants retained at 24 weeks of those randomized	24 weeks
Secondary	Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)	Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol.	Change from baseline to 12 weeks
Secondary	Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)	Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.	Change from baseline to 24 weeks
Secondary	Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)	Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.	Change from baseline to 12 weeks
Secondary	Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)	Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects.	Change from baseline to 24 weeks
Secondary	Change in Tumor Necrosis Factor-alpha (TNFa) From Before to After a12 Week Intervention (Optional)	tumor necrosis factor-alpha (TNFa) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better.	Change from baseline to 12 weeks
Secondary	Change in Tumor Necrosis Factor-alpha (TNFa) From Pre-Intervention to 24-week Follow-up (Optional)	tumor necrosis factor-alpha (TNFa) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better.	Change from baseline to 24 weeks
Secondary	Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)	C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better.	Change from baseline to 12 weeks
Secondary	Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)	C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better.	Change from baseline to 24 weeks
Secondary	Change in Triglycerides From Before to After a 12 Week Intervention (Optional)	Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.	Change from baseline to 12 weeks
Secondary	Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)	Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better.	Change from baseline to 24 weeks
Secondary	Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)	Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.	Change from baseline to 12 weeks
Secondary	Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)	Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.	Change from baseline to 24 weeks
Secondary	Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)	High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.	Change from baseline to 12 weeks
Secondary	Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)	High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.	Change from baseline to 24 weeks