NCT04348188

Brief Summary

AIM:To evaluate the effectiveness of a therapeutic exercise program (PET) in cancer patients in improving the quality of life and the need for supervision by health professionals during the performance of same after 6 weeks of intervention. DESIGN: Randomized and controlled clinical trial, parallel groups with active control group. With masking of randomization, patient evaluation and analysis of the data. SUBJETS OF STUDY: 58 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (inhibitors of aromatase, tamoxifen). INTERVENTION: both groups the treatment will be a common work-based therapeutic exercise program aerobic, strength-resistance and self-stretching, in addition to a reinforcement in recommendations usual self-care. The study includes two phases, phase of supervised work and phase of tracing. One of the groups will be supervised in the realization of PET for a period of 6weeks and the other group will do it autonomously and without supervision. The patients will be followed for 1 year, with five blind evaluations: at the beginning of the study, after 6 weeks of intervention, 3, 6 and 12 months after the start of the study.MEASUREMENTS: Principal: Quality of life assessed with the questionnaire measured with the European questionnaire Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Pre-post intervention measure, 3, 6 and 12 months. Secondary: Cancer-related fatigue evaluated with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Pre-post Measurement intervention, 3, 6 and 12 months. Functional capacity measured with the Test 6 minutes walking test. Pre-post Measurement intervention, 3, 6 and 12 months. Valuation of the measured force with manual hydraulic dynamometer and 5- test repetition sit-to-stand. Pre-post intervention measure, 3, 6 and 12 months.COST: effectiveness and cost / incremental utility associated to the program wil be estimated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

May 13, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

February 28, 2020

Last Update Submit

May 12, 2020

Conditions

Breast CancerColon Cancer

Keywords

Quality of lifeTerapeutic exerciseCancer

Outcome Measures

Primary Outcomes (1)

  • Changes in Health Related Quality of Life: EORTC QLQ-30

    Quality of life assessed with the questionnaire measured with the European questionnaire Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30. (EORTC QLQ-30). The QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions or items that assess the quality of life in relation to physical, emotional, social aspects and in general the level of functionality of patients diagnosed with cancer. The QLQ-C30 questionnaire is assigned values between 1 and 4 (1: not at all, 2: a little, 3: a lot, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with score from 1 to 7 (1: bad, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, 0 being the worst possible and 100 the best.

    Basal, 1.5, 3, 6, 12 months follow up

Secondary Outcomes (3)

  • Fatigue

    Basal, 1.5, 3, 6, 12 months follow up

  • Funtional capacity

    Basal, 1.5, 3, 6, 12 months follow up

  • Valuation of the measured force

    Basal, 1.5, 3, 6, 12 months follow up

Study Arms (2)

Supervised exercise group

EXPERIMENTAL

Supervised intervention group: 3 weekly sessions of 1 hour during 6 weeks of therapeutic exercise in which aerobic physical activity will be combined with exercise strength of different muscle groups plus stretches on a supervised basis and strengthening of self-care.

Behavioral: Education program on healthy habits

Not supervised exercise group

ACTIVE COMPARATOR

Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking.

Behavioral: Education program on healthy habits

Interventions

Education program on healthy habitsBEHAVIORAL

6-week supervised educational program with 12-month follow-up compared to the same unsupervised intervention

Not supervised exercise groupSupervised exercise group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-70 years.
  • Oncological stage I, II or III.
  • Completed adjuvant treatment between 3 months to 2 years. ECOG 1-2.
  • Sign informed consent

You may not qualify if:

  • Inability to read, understand and complete questionnaires, read and understand a brochure explanatory, understand and follow verbal orders (example; illiteracy, dementia or blindness).
  • Musculoskeletal disorders that prevent the exercise of the exercise bike, elliptical, march tape.
  • Important neurological disorders that involve impaired balance, coordination, ataxia.
  • Sporting activity at moderate intensity exceeding 150mnts / week.
  • Symptomatic anemia.
  • Fecal incontinence
  • Patient with a digestive ostomy.
  • Decompensated heart disease,
  • Uncontrolled hypertension
  • Heart failure.
  • Musculoskeletal pathology (except for upper limb pathology in cancer patients of mom)
  • Cardio-respiratory pathology that limits physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

MeSH Terms

Conditions

Breast NeoplasmsColonic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Pablo García

CONTACT

34913947273pablga25@ucm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2020

First Posted

April 16, 2020

Study Start

June 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2021

Last Updated

May 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)