NCT01866670

Brief Summary

Condition: patients with breast cancer. Intervention: spiritual support (relaxation + image guided + meditation) or relaxation in three consecutive meetings (day 2, 3 and 4), three days of intervention in the same week. The first day the participants will be evaluated if she meets the needs of the research and will answer questions about their indentification and spirituality. Type of study: intervention Study design: randomized controlled trial Masking: blind study. Randomization: sequence generated by SPSS (Statistical Package for the Social Sciences) version 15, organized in sealed envelopes by another qualified professional. The research ends in 2014 jun.

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
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

9 months

First QC Date

May 17, 2013

Last Update Submit

May 30, 2013

Conditions

Breast Neoplasms

Keywords

spiritual distressnursingbreast neoplasms

Outcome Measures

Primary Outcomes (1)

  • spirituality

    After this assessment, women who can participate in the research will answer questions about their identification (Identification Card of the study participants). They will answer five questions about spirituality (Pinto; Pais-Ribeiro, 2007); these questions also will be made at the end of the study, after sessions of relaxation or spiritual support to see if there was any change in the two stages and between the two groups (ANOVA). At the end they will give a score from 0 to 10, or give their opinion on the experience of the meetings (Experience Rating Scale). During relaxation or spiritual support, the study participants should allow being recorded heart rate, oxygen saturation and blood pressure (ANOVA); this will be done by means of a sensor (or electrode) as those used for ECG and results will appear on a monitor (monitor BM5).

    Spirituality Scale of Pinto and Pais-Ribeiro assessed at up to 1 week

Study Arms (2)

spiritual support

EXPERIMENTAL

-Spiritual Support: deep breathing + guided image + meditation Each patient will participate individually in three sequential meetings (A1, A2 and A3). In the experimental group, it will be developed the support spiritual intervention in all three meetings. In all meetings, namely A1, A2 and A3 the physiological parameters will be recorded (PA, SpO2, HR) through the monitor BM5.

Behavioral: spiritual support

relaxation therapy

ACTIVE COMPARATOR

Relaxation Therapy Each patient will participate individually in three sequential meetings (A1, A2 and A3). In the control group, it will be performed just relaxing in all three meetings. In all meetings, namely A1, A2 and A3 the physiological parameters will be recorded (PA, SpO2, HR) through the monitor BM5.

Behavioral: relaxation therapy

Interventions

spiritual supportBEHAVIORAL

-Spiritual Support: deep breathing + guided image + meditation

spiritual support
relaxation therapyBEHAVIORAL

Relaxation Therapy: deep breathing

relaxation therapy

Eligibility Criteria

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

You may not qualify if:

  • Present energy-reduction (Eastern Cooperative Oncology Group - ECOG/Zubrod Scale) - ECOG greater than 3
  • Present decreased cognition (Mini-Mental State Examination MMSE/Brucki et al. 2003) - lower sum related to grade school.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

REMA - Center for Education, Research and Rehabilitation assistence mastectomy

Ribeirão Preto, São Paulo, 14040902, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Caroline Guilherme, PhD student

CONTACT

055(16)3602-3475carolg@usp.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 31, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

BR(1)