Rehabilitation of Women Following Treatment for Gynaecological Cancer; a Randomized, Controlled Study

NCT01304745 | Unknown Phase 1 DMC

• 1 other identifier: 2009/896
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate and compare the effect of: 1 Educational and counselling in groups, 2) Physical training in group with 3) Control group, on global- and health related quality of life and coping in patients finished treatment for gynaecological cancer.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Global- and health related quality of life

  Pre intervention, post intervention and at one year follow-up

Secondary Outcomes (1)

• Coping strategies after gynaecological cancer

  Pre intervention, post intervention and at one year follow-up

Study Arms (3)

Physical traning in group

EXPERIMENTAL

Behavioral: Physical training in group

Educational and counselling group

EXPERIMENTAL

Behavioral: Educational and counseling in group

Control group

NO INTERVENTION

Interventions

Physical training in group BEHAVIORAL

Physical training in group, 6-9 participants, two times av week (1.5 hours) over a period of 16 weeks, focusing on strength and endurance training including body awareness and relaxation.

Also known as: Physical exercise

Physical traning in group

Educational and counseling in group BEHAVIORAL

Educational and counseling groups with 6-9 participants, with seven group meetings 2.5 hours over a period of seven weeks. Each session starts with a (20 minutes) lecture were one out of seven different topics are presented (Fatigue, sexuality, coping and coping strategies, etc).

Also known as: nurse-led patient education

Educational and counselling group

Eligibility Criteria

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

You may qualify if:

• Women finished treatment with a curative purpose independent of stage of cancer, type of gynaecological cancer, or previous gynaecological cancer
• Meet a certain physical functioning criteria (Specified as; manage to walk 3.1 miles per hour, lie down and rise up from the floor)
• To be willing to participate in the study for a period of 1- year and agrees to participate as specified conditions according to the consent form
• Not having any significant amnesic symptoms
• Women with other diagnosis were included as far as criterion 3 was fulfilled

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Margrethe Vika

Bergen, 5021, Norway

Location

MeSH Terms

Interventions

Population Groups; Exercise; Counseling

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Margrethe Vika, AP

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: October 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

NO (1)