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Ovarian InsufficiencyPhase 1NCT02181595

Deep Reading as a Contemplative Practice for Women With Primary Ovarian Insufficiency

A Phase 1 study testing Group reading and discussion in people with Ovarian Insufficiency, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Background: Women with Primary Ovarian Insufficiency (POI) have ovaries that stopped working normally before they turned 40. This usually causes infertility, which challenges many women with the condition to ask themselves, Why me? This kind of question is about our human existence, or what some call an existential… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Ovarian Insufficiency
What is being tested?
Group reading and discussion
How many people
6 participants
Where
1 siteUnited States
Study dates
2 Jul 2014to 20 Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • To be eligible for this research study, subjects must:
  • have previously enrolled in NICHD study 91-CH-0127, Ovarian Follicle Function in Patients with Primary Ovarian Insufficiency
  • agree to practice Deep Reading at least once each week outside of group sessions
  • agree to respect the privacy and confidentiality of other participants

Who cannot join

  • The following will be excluding from participating in the study:
  • those unable to give consent
  • those unwilling to participate in 6, 90 minute group sessions

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Deep Reading as a Contemplative Practice for Women With Primary Ovarian Insufficiency: An Exporatory Pilot Study.

Background:

  • Women with Primary Ovarian Insufficiency (POI) have ovaries that stopped working normally before they turned 40. This usually causes infertility, which challenges many women with the condition to ask themselves, Why me? This kind of question is about our human existence, or what some call an existential view of life. Researchers have learned that spirituality and finding existential purpose help women with POI. So does meeting other women with the same problem. Researchers want to find new ways to help women with POI cope with it.
Read more

Objective:

  • To develop and test a practice for women with POI called Deep Reading.

Eligibility:

  • Women enrolled in another POI protocol, who can read and speak English.

Design:

  • Participants will first have an individual visit or phone call. They will describe spiritual or existential practices they have done. They will also answer questions about spiritual and existential health and daily functioning.
  • They will join a group for 6 weekly sessions. Each session will be 60 90 minutes.
  • In each group session, a coordinator will teach participants about Deep Reading. They will read a piece of up to 1000 words. They will think about the piece and then talk about it with the group.
  • Between sessions, participants will practice Deep Reading at least once for 15 20 minutes on their own. They will check in once with another group member. They will keep a log of these activities.
  • After session 3, participants will answer questions online about wellbeing and satisfaction.
  • At session 6, participants will answer questions online about wellbeing. They will answer questions about their overall experience.
  • One and 3 months after the sessions end, participants will again complete online wellbeing questionnaires and report on their continued practice of Deep Reading.
Read the detailed description

It is well documented in the literature that women with Primary Ovarian Insufficiency find spirituality a valuable resource for coping with the existential dimension of the diagnosis. This is an exploratory pilot study which examines reading as a contemplative practice to assist these women as they attempt to come to terms with the life altering aspects of living with the diagnosis. In this intervention, that we call Deep Reading, up to 15 participants will engage in six weekly sessions approximately sixty to ninety minutes in length in which they will receive instruction on aspects of Deep Reading, practice Deep Reading and process the experience. Between group sessions participants will be asked to practice Deep Reading on their own and be paired for mutual support and encouragement. For convenience participants will be recruited from among those already enrolled in NICHD Protocol, Ovarian Follicle Function in Patients with Primary Ovarian Insufficiency (91-CH-0127). We will use the FACIT-Sp and satisfaction questionnaires to measure participant response and feasibility for future study.

Being tested
Group reading and discussion
Keywords
Reading, FACIT-SP, Primary Ovarian Insufficiency
Medical subject headings
Primary Ovarian Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group reading and discussionOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility based on Acceptability

    Measured: Recruitment Phase

  2. Feasibility based on Practicality of study

    Measured: throughout study

  3. Feasibility based on participant opinion

    Measured: end of study

Secondary outcomes (1)

  1. Changes in FACIT-Sp measure of spiritual well-being

    Measured: weekly, 1 mon, 3 mon

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2014 (estimated)
  2. Study start2 Jul 2014
  3. Primary completion20 Mar 2018
  4. Study completion20 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02181595
Sponsor's protocol ID
140139
Other IDs
14-CH-0139
Status last verified
20 Mar 2018
First submitted
2 Jul 2014
Last updated
16 Dec 2019
Results posted
No

Publications

  • Puchalski C, Ferrell B, Virani R, Otis-Green S, Baird P, Bull J, Chochinov H, Handzo G, Nelson-Becker H, Prince-Paul M, Pugliese K, Sulmasy D. Improving the quality of spiritual care as a dimension of palliative care: the report of the Consensus Conference. J Palliat Med. 2009 Oct;12(10):885-904. doi: 10.1089/jpm.2009.0142.

    PubMed 19807235

  • Boston P, Bruce A, Schreiber R. Existential suffering in the palliative care setting: an integrated literature review. J Pain Symptom Manage. 2011 Mar;41(3):604-18. doi: 10.1016/j.jpainsymman.2010.05.010. Epub 2010 Dec 8.

    PubMed 21145202

  • Murillo M, Holland JC. Clinical practice guidelines for the management of psychosocial distress at the end of life. Palliat Support Care. 2004 Mar;2(1):65-77. doi: 10.1017/s1478951504040088.

    PubMed 16594236

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Group reading and discussion in people with Ovarian Insufficiency, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility based on Acceptability (time frame: Recruitment Phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02181595, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.

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