NCT02706743

Brief Summary

The aim of this study was to assess the impact of adjuvant radioactive iodine therapy on the quality of life(QOL) in differentiated thyroid cancer patients and to identify independent factors affecting changes in the QOL.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

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

January 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

May 29, 2015

Last Update Submit

September 11, 2016

Conditions

Thyroid Neoplasms

Outcome Measures

Primary Outcomes (3)

  • Change in patients with differentiated thyroid cancer from baseline Medical Outcome Study Short-Form 36(MOS SF-36) questionnaire at 12 months

    The Medical Outcome Study Short-Form 36(MOS SF-36) is a short questionnaire with 36 items which measure eight multi-item variables: physical functioning (10 items), social functioning (two items), role limitations due to physical problems(four items), role limitations due to emotional problems (three items), mental health (five items), energy and vitality (four items), pain (two items), and general perception of health (five items). For each variable item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).

    baseline and 12 months

  • Change in patients with differentiated thyroid cancer from baseline Hospital Anxiety and Depression Scale at 12 months

    The Hospital Anxiety and Depression Scale HADS is a self-rated screening questionnaire detecting mild degrees of anxiety and depression. It consists of 14 questions, seven for anxiety and seven for depression. Scores range from non-cases (0-7 score), borderline cases(8-10 score), definite cases (11-21 score).

    baseline and 12 months

  • Change in patients with differentiated thyroid cancer from baseline Brief Fatigue Inventory at 12 months

    The instrument is used to quickly assess the severity of fatigue experienced by cancer patients, as well as its impact on their ability to function over the previous 24 h.The BFI consists of 9 items on a single page. Fatigue and its interference are measured on numeric scales from 0-10. There are three items asking subjects to describe their fatigue now, at its usual level, and at its worst level during the previous 24 hours, using extreme points "no fatigue" and "fatigue as bad as you can imagine." The next six items describe how much fatigue has interfered with aspects of their life during the previous 24 hours. Specifically, these items are general activity, mood, walking ability, normal work (both work outside the home and daily chores), relations with other people, and enjoyment of life. These interference scales range from "0" ("does not interfere") to "10" ("completely in terferes"). The global score for the BFI is calculated as the mean value of these 9 items.

    baseline and 12 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with differentiated thyroid cancer initially referred to adjuvant radioiodine treatment in nuclear medicine department, Zhujiang Hospital, Southern Medical University.

You may qualify if:

  • Pathologically confirmed new diagnosis of differentiated thyroid cancer, recently treated by total thyroidectomy
  • Must sign a consent form before treatment
  • One year or more of follow-up after radioiodine ablation

You may not qualify if:

  • Patients with follicular, Hürthle cell, poorly differentiated, medullary, or anaplastic thyroid carcinoma
  • Pregnant or lactating women
  • Patients that received adjuvant radioiodine treatment in the past
  • Patients with other cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Sun Y Gang, Master

    Zhujiang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Y Gang, Master

CONTACT

8602062783296yungangsun@foxmail.com

OU Y Wei, Master

CONTACT

8613600474406oyw88@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2015

First Posted

March 11, 2016

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

CN(1)