NCT02716467

Brief Summary

Living with breast cancer and forms of treatment, among them radiation therapy can cause both side effects such as pain, fatigue and skin changes that affect the well-being, as anxiety, feelings of isolation and changes in routine, which generate existential conflicts and allow the origin of the spiritual anguish phenomenon, which in turn, aggravates the physical and emotional symptoms and the ability to fight the disease. Thus, this study aims to evaluate the effect of intercessory prayer on levels of spiritual distress, religious / spiritual coping, psychological morbidity (anxiety and depression) and amylase levels salivary present in patients with breast cancer radiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2016

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

March 6, 2016

Last Update Submit

November 23, 2020

Conditions

Breast Cancer

Keywords

nursingintercessory prayerspiritualityclinical trials

Outcome Measures

Primary Outcomes (1)

  • Spiritual Distress assessed using a scale

    spiritual distress

    an average of 1 year

Secondary Outcomes (3)

  • Anxiety and Depression assessed using a scale

    an average of 1 year

  • anxiety assessed per physiological parameter using saliva

    an average of 1 year

  • Short Spiritual Religious Coping assessed using a scale

    an average of 1 year

Study Arms (2)

intercessory prayer group

EXPERIMENTAL

Patients in the experimental group receive prayer of intercession during radiotherapy treatment.

Other: intercessory prayerRadiation: Radiotherapy

Radiotherapy Treatment

ACTIVE COMPARATOR

Patients in the radiotherapy group not receive prayer of intercession during radiotherapy treatment.

Radiation: Radiotherapy

Interventions

intercessory prayerOTHER

Intercessory prayer will be offered by a group of six Christian people.

intercessory prayer group
RadiotherapyRADIATION

All participants will receive treatment by radiotherapy

Radiotherapy Treatmentintercessory prayer group

Eligibility Criteria

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

You may qualify if:

  • Individuals diagnosed with breast cancer in adjuvant and neoadjuvant radiotherapy treatment;
  • Both female and male participants are being studiedolder;
  • Minimum age of participants is 18 years.

You may not qualify if:

  • Not being with consciousness, memory and orientation preserved;
  • Patients with clinical conditions that affect the continuity in the study or express request not to continue participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiotherapy Clinic of the Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14040-902, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Emília C. Carvalho, PhD

    Ribeirão Preto College of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student of the Nursing Doctoral

Study Record Dates

First Submitted

March 6, 2016

First Posted

March 23, 2016

Study Start

April 1, 2015

Primary Completion

July 15, 2015

Study Completion

May 15, 2016

Last Updated

November 27, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)