Women's Activity and Lifestyle Study in Connecticut

NCT02107066 | Completed Phase 3 DMC

• 2 other identifiers: 0904004976R01CA138556
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Despite an increase in longevity, surviving ovarian cancer often brings an array of unpleasant side effects and compromises in QOL. Our proposed trial will be the first study to test whether exercise compared with attention control has a beneficial impact on quality of life, fitness and surrogate markers of ovarian cancer. Our trial could suggest a unique and important role for exercise in ovarian cancer care given that physical and functional aspects of QOL are often the most compromised in ovarian cancer patients.

Conditions

Ovarian Cancer

Keywords

exercise; physical activity; ovarian cancer; quality of life; fatigue; weight

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian (FACT-O)

  The FACT-General (FACT-G) consists of four subscales that measure wellbeing in physical, social, emotional and functional domains. The FACT-Ovarian (FACT-O) is a disease-specific measure and is comprised of the four subscales from the FACT-G in addition to a set of items that address concerns specific to ovarian cancer

  6 months

• Change from Baseline in Functional Assessment of Cancer Therapy-Fatigue (FACT-F)

  FACT-F is a self-reporting questionnaire comprised of 13 fatigue-related items. Each item on the FACT-F is answered on a five-point scale and summed, with total scores ranging between 0 and 52. Lower scores indicate greater self-reported fatigue.

  6 months

• Change from Baseline in Short Form 36 (SF-36)

  The SF-36 survey was interpreted using eight subscales (emotional, functional, pain, physical, roles-emotional, roles-physical, social, vitality) that can be combined into physical (PCS) and mental (MCS) component summary scores. The PCS score describes physical health and is composed of the general health, pain, physical functioning, and role-physical subscales. The MCS score describes mental health and is comprised of mental health, role-emotional, social functioning, and vitality subscales.

  6 months

Study Arms (2)

attention control

ACTIVE COMPARATOR

Women randomized to attention control will receive the same attention as women randomized to exercise intervention, i.e., weekly phone calls for 6 months. Each call is about 15 min. Women in the attention control will receive information on ovarian cancer health education topics.

Behavioral: Exercise

exercise

EXPERIMENTAL

Women randomized to exercise will receive telephone-counseling weekly for 6 months to increase their exercise

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.

attention control; exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage I-IV ovarian cancer
• less than 76 yrs of age

You may not qualify if:

• exercising

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Related Publications (3)

• Cao A, Cartmel B, Li FY, Gottlieb LT, Harrigan M, Ligibel JA, Gogoi R, Schwartz PE, Esserman DA, Irwin ML, Ferrucci LM. Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy Among Patients Treated for Ovarian Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326463. doi: 10.1001/jamanetworkopen.2023.26463.

  PMID: 37526937 DERIVED

• Cartmel B, Li FY, Zhou Y, Gottlieb L, Lu L, Mszar R, Harrigan M, Ligibel JA, Gogoi R, Schwartz PE, Risch HA, Irwin ML. Randomized trial of exercise on cancer-related blood biomarkers and survival in women with ovarian cancer. Cancer Med. 2023 Jul;12(14):15492-15503. doi: 10.1002/cam4.6187. Epub 2023 Jun 3.

  PMID: 37269192 DERIVED

• Cao A, Cartmel B, Li FY, Gottlieb LT, Harrigan M, Ligibel JA, Gogoi R, Schwartz PE, Irwin ML, Ferrucci LM. Effect of exercise on body composition among women with ovarian cancer. J Cancer Surviv. 2023 Oct;17(5):1386-1396. doi: 10.1007/s11764-022-01207-x. Epub 2022 Apr 4.

  PMID: 35377104 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Motor Activity; Fatigue; Body Weight

Interventions

Exercise

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Melinda Irwin, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: April 8, 2014
• Study Start: May 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 20, 2018

Record last verified: 2014-04

Locations

US (1)