Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors

Northwestern University

Status: Completed

Conditions: Physical Activity; Breast Cancer Female

Treatments: Behavioral: Support Calls; Behavioral: Online gym; Behavioral: App notifications; Behavioral: Buddy; Behavioral: App+; Behavioral: Core

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03131440

R21CA219028-01A1 (U.S. NIH Grant/Contract)

K07CA196840 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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280 participants in 32 patient groups

Experimental Condition #1

Experimental group

Description:

core, support calls

Treatment:

Behavioral: Core

Behavioral: Support Calls

Experimental Condition #2

Experimental group

Description:

core, support calls, app+

Treatment:

Behavioral: Core

Behavioral: Support Calls

Behavioral: App+

Experimental Condition #3

Experimental group

Description:

core, support calls, buddy

Treatment:

Behavioral: Core

Behavioral: Support Calls

Behavioral: Buddy

Experimental Condition #4

Experimental group

Description:

core, support calls, online gym

Treatment:

Behavioral: Core

Behavioral: Support Calls

Behavioral: Online gym

Experimental Condition #5

Experimental group

Description:

core, support calls, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Support Calls

Experimental Condition #6

Experimental group

Description:

core, app+

Treatment:

Behavioral: Core

Behavioral: App+

Experimental Condition #7

Experimental group

Description:

core, app+, buddy

Treatment:

Behavioral: Core

Behavioral: App+

Behavioral: Buddy

Experimental Condition #8

Experimental group

Description:

core, app+, online gym

Treatment:

Behavioral: Core

Behavioral: Online gym

Behavioral: App+

Experimental Condition #9

Experimental group

Description:

core, app+, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: App+

Experimental Condition #10

Experimental group

Description:

core, buddy

Treatment:

Behavioral: Core

Behavioral: Buddy

Experimental Condition #11

Experimental group

Description:

core, buddy, online gym

Treatment:

Behavioral: Core

Behavioral: Online gym

Behavioral: Buddy

Experimental Condition #12

Experimental group

Description:

core, buddy, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Buddy

Experimental Condition #13

Experimental group

Description:

core, online gym

Treatment:

Behavioral: Core

Behavioral: Online gym

Experimental Condition #14

Experimental group

Description:

core, online gym, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Online gym

Experimental Condition #15

Experimental group

Description:

core, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Experimental Condition #16

Experimental group

Description:

core, support calls, app+, buddy

Treatment:

Behavioral: Core

Behavioral: Support Calls

Behavioral: App+

Behavioral: Buddy

Experimental Condition #17

Experimental group

Description:

core, support calls, app+, online gym

Treatment:

Behavioral: Core

Behavioral: Support Calls

Behavioral: Online gym

Behavioral: App+

Experimental Condition #18

Experimental group

Description:

core, support calls, app+, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Support Calls

Behavioral: App+

Experimental Condition #19

Experimental group

Description:

core, support calls, buddy, online gym

Treatment:

Behavioral: Core

Behavioral: Support Calls

Behavioral: Online gym

Behavioral: Buddy

Experimental Condition #20

Experimental group

Description:

core, support calls, buddy, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Support Calls

Behavioral: Buddy

Experimental Condition #21

Experimental group

Description:

core, support calls, online gym, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Support Calls

Behavioral: Online gym

Experimental Condition #22

Experimental group

Description:

core, app+, buddy, online gym

Treatment:

Behavioral: Core

Behavioral: Online gym

Behavioral: App+

Behavioral: Buddy

Experimental Condition #23

Experimental group

Description:

core, app+, buddy, online gym, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Online gym

Behavioral: App+

Behavioral: Buddy

Experimental Condition #24

Experimental group

Description:

core, support calls, buddy, online gym, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Support Calls

Behavioral: Online gym

Behavioral: Buddy

Experimental Condition #25

Experimental group

Description:

core, buddy, online gym, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Online gym

Behavioral: Buddy

Experimental Condition #26

Experimental group

Description:

core, app+, online gym, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Online gym

Behavioral: App+

Experimental Condition #27

Experimental group

Description:

core, support calls, app+, buddy, online gym

Treatment:

Behavioral: Core

Behavioral: Support Calls

Behavioral: Online gym

Behavioral: App+

Behavioral: Buddy

Experimental Condition #28

Experimental group

Description:

core, support calls, app+, buddy, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Support Calls

Behavioral: App+

Behavioral: Buddy

Experimental Condition #29

Experimental group

Description:

core, support calls, app+, online gym, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Support Calls

Behavioral: Online gym

Behavioral: App+

Experimental Condition #30

Experimental group

Description:

core

Treatment:

Behavioral: Core

Experimental Condition #31

Experimental group

Description:

core, app+, buddy, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: App+

Behavioral: Buddy

Experimental Condition #32

Experimental group

Description:

core, support calls, app+, buddy, online gym, app notifications

Treatment:

Behavioral: App notifications

Behavioral: Core

Behavioral: Support Calls

Behavioral: Online gym

Behavioral: App+

Behavioral: Buddy