Telehealth System to Improve Quality of Life in Breast Cancer Survivors

NCT01801527 | Completed DMC

• 1 other identifier: PI10/02749-02764
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cancer is increasingly viewed as a chronic disease and therefore there is a growing need for long-term treatments. Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increases the prevalence of conditions associated to unhealthy life-style. Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short and long-term effects telehealth program. Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio Hospital and associations of breast cancer patients in Granada. Patients will be randomized to receive the online rehabilitation group (n=36) or usual care (control) group (n=36). Telerehabilitation group will receive an eight-week online intervention and control group receive recommendations about usual care. Discussion: The investigators study attempts to increase the level of fitness and reduce musculoskeletal disorders in breast cancer patients through a strategy for care based on telerehabilitation to promote therapeutic exercise.

Conditions

Breast Cancer

Keywords

Telehealth; Fatigue; Breast cancer; Exercise; Quality of life; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Quality of life

  The primary outcome will be assessed with The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. This questionnaire includes both multi-item scales and single-item measures. These are composed by five functional scales, three symptom scales, a global health status/QoL scale, and six single items. The scores have to be averaged and transformed linearly to obtain a range of score from 0 to 100 where high score meaning a great response level. The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23) which is a breast cancer module of EORTC QLQ-C30 will also be assessed

  Participants will be followed over 8 weeks

Secondary Outcomes (10)

• Algometry

  Participants will be followed over 8 weeks

• The Visual Analogue Scale (VAS) for pain

  Participants will be followed over 8 weeks

• Pain

  Participants will be followed over 8 weeks

• Body composition

  Participants will be followed over 8 weeks

• Physical measurement

  Participants will be followed over 8 weeks

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

Behavioral: Telerehabilitation group

Control group

NO INTERVENTION

Information about usual care

Interventions

Telerehabilitation group BEHAVIORAL

Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system

Telerehabilitation group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of stage I, II, or IIIA breast cancer
• Medical clearance of participation
• Without chronic disease or orthopaedic that would interfere with ability to participate in a physical activity program
• Access to Internet
• Basic ability to use the computer or living with a relative who has this ability
• Completion of adjuvant therapy except for hormone therapy
• No history of cancer recurrence
• Have interest in improving lifestyle: fitness/stress level
• Have signed informed consent

Sponsors & Collaborators

• Universidad de Granada: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Faculty of Health Sciences. University of Granada

Granada, 18071, Spain

Location

Related Publications (2)

• Galiano-Castillo N, Arroyo-Morales M, Ariza-Garcia A, Fernandez-Lao C, Fernandez-Fernandez AJ, Cantarero-Villanueva I. Factors that Explain the Cancer-Related Insomnia. Breast J. 2017 Jul;23(4):387-394. doi: 10.1111/tbj.12759. Epub 2017 Jan 24.

  PMID: 28117498 DERIVED

• Galiano-Castillo N, Ariza-Garcia A, Cantarero-Villanueva I, Fernandez-Lao C, Diaz-Rodriguez L, Legeren-Alvarez M, Sanchez-Salado C, Del-Moral-Avila R, Arroyo-Morales M. Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial. Trials. 2013 Jun 22;14:187. doi: 10.1186/1745-6215-14-187.

  PMID: 23799886 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Manuel Arroyo-Morales, PhD

  Faculty of Health Sciences. University of Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: February 28, 2013
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

ES (1)