NCT01416909

Brief Summary

The purpose of this research is to evaluate the effectiveness of the Constipation Treatment Protocol and to test whether management according to dose of constipation-inducing medications or according to on-going assessment is most effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
601

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

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

November 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 23, 2017

Status Verified

March 1, 2015

Enrollment Period

4.8 years

First QC Date

August 11, 2011

Last Update Submit

February 21, 2017

Conditions

Constipation

Keywords

Medication-inducedConstipation in Cancer

Outcome Measures

Primary Outcomes (1)

  • Phase I - Record Constipation Incidence and Symptoms

    To identify the incidence, severity, distress and trajectory of constipation in cancer patients receiving opioids over an eight week period and to evaluate the relationships between constipation intensity and opioid dose. To identify the incidence, severity, distress and trajectory of constipation in groups of cancer patients who may be at risk due to vinca alkaloids (vincristine. vinblastine. vinorelbine and vindesine) over an eight week period and to evaluate the relationship between constipation intensity and vinca alkaloid dose.

    18 months

Secondary Outcomes (2)

  • Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation

    2 years, 3 months

  • Phase II - Best Determination of Laxative Dose - Patients with Medication-induced Constipation

    2 years, 3 months

Study Arms (5)

Dose Intervention - Opioid

ACTIVE COMPARATOR

Laxative Treatment: Participants Receiving Opioids for the Treatment of Pain. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be based on the dose of the opioid pain medication they are receiving.

Other: Laxative TreatmentOther: Assessment Questionnaires

Assessment Intervention - Opioid

ACTIVE COMPARATOR

Laxative Treatment: Participants Receiving Opioids for the Treatment of Pain. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be determined based on their severity of constipation.

Other: Laxative TreatmentOther: Assessment Questionnaires

Control Group - Opioid

OTHER

Standard of Care: Participants Receiving Opioids for the Treatment of Pain will receive their usual care at Moffitt while participating in weekly assessments. After participation in the study is complete, participants will be offered the same protocol that is given to patients in the treatment groups.

Other: Standard of CareOther: Assessment Questionnaires

Assessment Intervention - Vinca Alkaloid

ACTIVE COMPARATOR

Laxative Treatment: Participants Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine. Participants will be taken off any laxative preparation they may already be on and will be put on laxative treatment based on the Constipation Treatment Protocol. The dose of laxative will be based on their level of constipation.

Other: Laxative TreatmentOther: Assessment Questionnaires

Control Group - Vinca Alkaloid

OTHER

Standard of Care: Participants Receiving a Specific Type of Chemotherapy (vinca alkaloids). Vinca alkaloids include medication such as Vincristine, Vinblastine, or Vinorelbine. Patients will receive standard of care while participating in weekly assessments. After participation in the study is complete, participants will be offered the same protocol that is given to patients in the treatment groups.

Other: Standard of CareOther: Assessment Questionnaires

Interventions

Laxative TreatmentOTHER

Participants will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol.

Also known as: constipation treatment
Assessment Intervention - OpioidAssessment Intervention - Vinca AlkaloidDose Intervention - Opioid
Standard of CareOTHER

Participants will receive their usual care at Moffitt while participating in weekly assessments. After participation in the study is complete, participants will be offered the same protocol that is given to patients in the treatment groups.

Control Group - OpioidControl Group - Vinca Alkaloid
Assessment QuestionnairesOTHER

Constipation Assessment Scale (CAS), Laxative Interview (based on Laxative Diary completed by patients), Memorial Symptom Assessment Scale (MSAS), Functional Assessment of Cancer Therapy-General (FACT-G).

Assessment Intervention - OpioidAssessment Intervention - Vinca AlkaloidControl Group - OpioidControl Group - Vinca AlkaloidDose Intervention - Opioid

Eligibility Criteria

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

You may qualify if:

  • The study sample will consist of patients who are receiving outpatient care at the Moffitt Cancer Center.
  • Patients will be identified as those who have a diagnosis of cancer and are being treated with either opioids or vinca alkaloids,
  • are adults (or children 18-21 years old),
  • either male or female,
  • able to read and understand English,
  • and able to pass screening with the Short Portable Mental Status Questionnaire and Karnofsky Performance Status Scale.

You may not qualify if:

  • Patients will be excluded: if they have non-melanoma skin cancer or colorectal or gynecological cancer as their primary diagnosis;
  • if they are excessively debilitated or deemed unlikely to survive for the eight weeks of the data collection period;
  • if they are unable to read and understand English;
  • if they have an ostomy that changes bowel function;
  • if they have a current peritoneal catheter;
  • if they have had abdominal surgery within the past six weeks;
  • or have a disease process suggestive of mechanical obstruction (tumor or adhesion);
  • if they have a history of chronic bowel disease (including irritable bowel syndrome, chronic constipation prior to cancer onset, Crohn's disease, ulcerative colitis or diarrhea as a result of radiation to the pelvis), or report chronic laxative use prior to cancer onset.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Susan McMillan, Ph.D., RN

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 15, 2011

Study Start

November 1, 2008

Primary Completion

August 1, 2013

Study Completion

January 1, 2014

Last Updated

February 23, 2017

Record last verified: 2015-03

Locations

US(1)