Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors

NCT03367923 | Completed Phase 2

• 3 other identifiers: IRB-43094NCI-2017-02149GYNEND0002
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized phase II trial studies how well a health and recovery program works in increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text communication may increase the level of physical activity in endometrial cancer survivors and promote and maintain behavior change at a lower cost.

Conditions

Cancer Survivor; Endometrial Carcinoma; Stage I Uterine Corpus Cancer AJCC v7; Stage IA Uterine Corpus Cancer AJCC v7; Stage IB Uterine Corpus Cancer AJCC v7; Stage II Uterine Corpus Cancer AJCC v7; Stage IIIA Uterine Corpus Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• Increase in activity level measured using Fitbit tracker

  The increase in activity level will be determined where the baseline average number of steps recorded per patient during week 0 - 2 will be compared to the average step count recorded during week 20 - 28. The baseline measurement will be defined as the average step count reported by the patient during 0-2 weeks. At each subsequent time point the average step count per patient will be the average of the step counts recorded during the 2-4 weeks prior to the follow up visit. The average step count measured at 20-28 weeks will be compared to the baseline in a paired t test. The paired t test will

  Up to week 20-28

Secondary Outcomes (7)

• Body mass index (BMI)

  Up to 9 months

• Pulse

  Up to 9 months

• Blood pressure

  Up to 9 months

• Quality of life assessment using Functional Assessment of Cancer Therapy-General (FACT-G)

  Up to 9 months

• Rate of increased activity level measured using Fitbit tracker

  Up to week 20-28

Study Arms (2)

Arm I (exercise counseling, Fitbit, phone call)

EXPERIMENTAL

Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive a short phone call at 2, 4, 6, and 8 weeks, and at 4 and 5 months to discuss the average number of daily steps over the past 2 weeks and to encourage a goal of a 10% increase over the next 2-4 week time period.

Other: Counseling; Other: Fitbit tracker; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

Arm II (exercise counseling, Fitbit, email/text)

EXPERIMENTAL

Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily for 9 months. Participants receive an electronic communication (email/text) of their choice at 2, 4, 6, and 8 weeks, and at 4 and 5 months stating the average number of daily steps over the past 2 weeks and encouraging a goal of a 10% increase over the next 2-4 week time period.

Other: Communication Intervention; Other: Counseling; Other: Fitbit tracker; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Communication Intervention OTHER

Receive email/text

Arm II (exercise counseling, Fitbit, email/text)

Counseling OTHER

Undergo exercise counseling

Also known as: Counseling Intervention

Arm I (exercise counseling, Fitbit, phone call); Arm II (exercise counseling, Fitbit, email/text)

Fitbit tracker OTHER

Wear Fitbit tracker

Also known as: Device

Arm I (exercise counseling, Fitbit, phone call); Arm II (exercise counseling, Fitbit, email/text)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (exercise counseling, Fitbit, phone call); Arm II (exercise counseling, Fitbit, email/text)

Questionnaire Administration OTHER

Ancillary studies

Arm I (exercise counseling, Fitbit, phone call); Arm II (exercise counseling, Fitbit, email/text)

Telephone-Based Intervention BEHAVIORAL

Receive phone call

Arm I (exercise counseling, Fitbit, phone call)

Eligibility Criteria

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

You may qualify if:

• Stage IA-IIIA endometrial cancer patients with pathology reviewed at Stanford
• Patients must have undergone surgery as a part of their treatment for their endometrial cancer
• At least 3 months post treatment
• BMI \> 25
• Life expectancy of at least one year
• Able to perform physical activity of walking
• Possession of a computer and/or smart phone and/or smart tablet
• Must be English or Spanish speaking

You may not qualify if:

• Other active cancer
• Receiving chemotherapy or other active treatment
• BMI \< 60
• Diagnosis of uterine serous carcinoma or uterine sarcoma

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

Stanford Cancer Center South Bay

San Jose, California, 95124, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Counseling; Equipment and Supplies

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Elizabeth Kidd

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 11, 2017
• Study Start: December 1, 2017
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

US (2)